[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"contraception\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:contraception":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,48,0,25,[9,43,69,97,127,153,172,196,228,249,270,294,321,364,391,420,440,463,483,510,534,557,583,602,628],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100457480","phase-4-etonogestrel-implant-as-emergency-contraception-100457480",false,"NCT05237141","Etonogestrel Implant as Emergency Contraception","Etonogestrel Implant as Emergency Contraception: A Pilot Pharmacodynamic Study","Inclusion Criteria:\n\n* BMI less than or equal to 28kg\u002Fm2\n* Intact uterus with at least one ovary\n* Regular menstrual cycles that occur every 21-35 days\n* If patient is postpartum or post-second trimester abortion, 3 menses (2 cycles) must have occurred prior to enrollment\n* If patient had a first trimester abortion or pregnancy loss, she must have one spontaneous menses prior to enrollment\n* Desires insertion of an etonogestrel contraceptive implant for contraception\n* Not currently pregnant or trying to become pregnant\n* Willing to abstain from medications and supplements known to induce\u002Finhibit CYP3A4 during the study\n\nExclusion Criteria:\n\n* Have a known hypersensitivity or contraindications to etonogestrel.\n* Medical conditions that affect liver function (e.g., hepatitis, cirrhosis; assessed via participant self-report)\n* Known or suspected current alcohol dependence syndrome or any illicit drug use that may affect the metabolism of the etonogestrel.\n* Uncontrolled thyroid disorder.\n* Use of long-acting injectable hormonal contraceptive within the past 9 months\n* Current use of hormonal oral, patch, intravaginal, or intrauterine contraception",true,"FEMALE","18 Years","40 Years",{"count":22,"type":23},12,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","The investigators propose a single site, single arm, open label mechanism of action pharmacodynamic pilot study of etonogestrel implant insertion prior to an luteinizing hormone (LH) surge. The investigators will evaluate ovulation rates via serum levels of reproductive hormones and transvaginal ultrasound findings following placement of an etonogestrel implant once the dominant follicle reaches a size of 15mm or greater, but prior to an LH surge, in persons with prior documented regular cycles and confirmed ovulation. The researchers' hypothesis is that ovulation will be inhibited if the etonogestrel implant is placed prior to an LH surge.\n\nBased on data from the Food and Drug Administration label for Nexplanon, etonogestrel rises to levels associated with ovulation suppression within 8 hours of placement. Given this rapid increase, it is therefore plausible to assume that ovulation can be inhibited by the implant if placed prior to an LH surge. This study is novel as there have been no published studies evaluating an etonogestrel implant for this indication.\n\nThe contribution of this proposed research to the literature is significant because current recommendations from the Center for Disease Control (CDC) regarding timing of etonogestrel implant placement are stringent and not patient-centered. Any day insertion of the etonogestrel implant is supported by retrospective data and this pharmacodynamic data would further support the literature for any day insertion without the need for additional emergency contraception. If results support the investigators' hypothesis, it could increase access to contraception and decrease duplicative therapy.",[29],"Contraception","RECRUITING","2026-08-10",{"date":33,"type":34},"2026-08-11","ACTUAL",{"date":36,"type":34},"2022-04-01",{"date":38,"type":23},"2027-12",{"name":40,"class":41},"University of Colorado, Denver","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":17,"sex":18,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":67,"locationsCount":42},"100362119","project-for-reproductive-equity-through-volunteers-and-entrepreneurship-networks-and-technology-100362119","NCT03995043","Project for Reproductive Equity Through Volunteers and Entrepreneurship, Networks and Technology","Project for Reproductive Equity Through Volunteers and Entrepreneurship, Networks and Technology: The PREVENT Project Protocol","PREVENT","Inclusion Criteria:\n\n* Women 15-19 years of age\n* Reside within the study area for the duration of the study\n* Have a personal mobile phone and be willing to provide the phone number to the researchers to receive the intervention messages\n* Report being SMS literate (ie. able to read text messages in English or Swahili)\n* Be able and willing to return for follow-up after 12 months\n* Be able and willing to give written informed consent for enrollment in the study\n\nExclusion Criteria:\n\n* Be pregnant or planning pregnancy within 12 months (assessed when obtaining consent using HCG (human chorionic gonadotropin) urine dipstick).\n* Participation in another study or intervention that may affect the outcome of this study\n* Already utilizing a long-term form of contraception such as intra-uterine device, or implantable or inject-able contraception\n* Having a non-medical condition detected through screening that hinders study participation such as developmental or cognitive delay","15 Years","19 Years",{"count":54,"type":23},198,[56],"NA","The PREVENT Project is a multifaceted, adolescent friendly, culturally competent program aimed to address the issues surrounding unplanned pregnancies and lack of access and uptake of contraceptive services among adolescent girls. The intervention uses a mobile platform that provides educational SMS (Short Message Service) messaging, interactive voice response, and connects adolescent girls to community based AFSRH (Adolescent Friendly Sexual Reproductive Health) counselling services, as well as discreet contraceptive access points headed by female entrepreneurs. The program will be piloted for 12 months in various wards and villages in rural and urban Kilimanjaro, Tanzania.The acceptability and practicality of the intervention will be assessed using mixed methods. Questionnaires and focus groups will be conducted with the study participants, as well as the medical and non-medical volunteers at the start and end of the pilot. The study will be heavily supported by all-female non-medical social entrepreneurs and sexual reproductive health community mentors (volunteers), and, all-female medical reproductive health team. Recruitment will also take place in hair saloons (local hair braiding and styling establishments) and other female run business such as tailors and female clothing stores that have enlisted to become contraceptive access points in the study. There will be 2 intervention groups, control and case group. Both groups will receive educational SMS (text) messages on SRH (Sexual Reproductive Health) and access individually tailored educational resources through interactive voice response (IVR) services\u002Fsystem via PREVENT mobile platform. In addition to personal support to be able to contact with a SRH community peer mentor in the community for AFSRH counselling and support. The case group will then have access to contraception provided with detailed and discreet information on accessing PREVENT contraceptive access points in all communities included in the study.",[29,59,60],"Pregnancy Related","Reproductive Behavior","NOT_YET_RECRUITING",{"date":63,"type":34},"2026-08-12",{"date":38,"type":23},{"date":66,"type":23},"2029-06-01",{"name":68,"class":41},"Dr. Karen Yeates",{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":24,"phases":79,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100608426","phase-2-long-term-evaluation-of-scapular-inserted-contraceptive-implants-100608426","NCT07201402","Long Term Evaluation of Scapular-inserted Contraceptive Implants","Prospective Long-term Study of Etonogestrel Contraceptive Implant Insertion at an Alternative Scapular Site","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Sex assigned at birth must be Female\n4. Aged 18-45 years\n5. In good general health as evidenced by medical history and no need for regular intensive medical interventions (e.g., inpatient admissions, surgical treatments). The Principal Investigator will be responsible for determining good general health for potential participants with complicated medical histories\n6. Interest and willingness to use an etonogestrel contraceptive implant\n7. Negative pregnancy test at the time of study enrollment and not planning to become pregnant in the next 36 months\n8. Willing to abstain from medications and supplements known to induce\u002Finhibit CYP3A (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort) during the study. In the inducer\u002Finhibitor CYP3A medication is a prescribed medication, individuals must provide the prescriber information for the PI to confirm it is safe for this medication to be abstained during the study\n9. Body-mass index ≥18.5kg\u002Fm2\n\nExclusion Criteria:\n\n1. Self-reported contraindications to the use of the ENG implant based on the CDC Medical Eligibility Criteria guidelines for any conditions with a category 3 or 4 recommendation\n\n   1. Current breast cancer or personal history of breast cancer\n   2. Malignant liver tumor (hepatocellular carcinoma)\n   3. Allergic reaction to any components of the ENG implant\n2. Any self-reported known liver conditions that could affect drug metabolism (e.g., cirrhosis, hepatitis)\n3. Personal history of deep vein thrombosis (DVT), venous thromboembolism (VTE), or arterial thromboembolism (ATE).\n4. Currently taking and unable or unwilling to abstain from any medications or supplements known to be CYP3A inducers\u002Finhibitors.\n5. Current use of a progestin-only contraceptive method containing desogestrel or etonogestrel\n6. History of spinal deformity (e.g., kyphosis, lordosis)\n7. History of shoulder or scapular surgery on the non-dominant side\n8. Non-dominant shoulder mobility limitations\n9. Previous trauma to the non-dominant scapular region\n10. Active skin conditions (e.g., psoriasis) in the non-dominant scapular region\n11. Inability to palpate the bony landmarks of the scapula due to adiposity or other body habitus","45 Years",{"count":78,"type":23},62,[80],"PHASE2","This study aims to evaluate long-term outcomes when the etonogestrel contraceptive implant is inserted at an alternative site located over the scapular. The study will evaluate the pharmacokinetics (i.e., drug levels) and side effect profiles of participants who have an etonogestrel contraceptive implant inserted at this alternative scapular site over the course of at least two years.",[29],[84,85,86],"contraceptive implant","scapular insertion site","etonogestrel","2026-07-24",{"date":89,"type":34},"2026-07-27",{"date":91,"type":34},"2026-05-08",{"date":93,"type":23},"2027-10",{"name":95,"class":41},"Yale University",2,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":24,"phases":108,"briefSummary":109,"conditions":110,"keywords":111,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":42},"100647546","i-can-uganda-effectiveness-trial-100647546","NCT07711717","I-CAN Uganda Effectiveness Trial","Cluster Randomized Controlled Trial of the \"I-CAN\" Peer Support Intervention to Improve Contraceptive Agency in in Rural Uganda","I-CAN","Inclusion Criteria:\n\n* Woman\n* Ages 18-49 years\n\nExclusion Criteria:\n\n* Women who are not able to respond to the survey questions on their own\n* Not usual resident in study village\n* Not consenting to the survey","49 Years",{"count":107,"type":23},1560,[56],"This is a cluster-randomized controlled trial to determine the effectiveness of the community-based \"I-CAN\" intervention to improve agency in contraceptive decision-making and use in rural Uganda. Lay women will be trained to serve as peer mentors to other women of reproductive age in the community, using their own lived experience to provide support and information about contraceptive choices.\n\nVillages will be randomized to either receive the intervention or not. A household survey will be conducted at baseline before implementation activities begin and 24 months later. Interviews will also be conducted with mentors, participants, male partners of participants and other stakeholders.\n\nResearchers will compare preference-aligned contraceptive use (primary outcome), contraceptive agency, contraceptive method satisfaction, preference-aligned fertility management, and use of self-injectable contraception in villages with and without the intervention to determine effectiveness.",[29],[112,113,114,115,116,117],"Preference-aligned contraceptive use","Self-injectable contraception","Contraceptive agency","Peer social support","Uganda","Rural","2026-07-21",{"date":120,"type":34},"2026-07-23",{"date":122,"type":23},"2026-10-13",{"date":124,"type":23},"2028-12-31",{"name":126,"class":41},"University of California, San Francisco",{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":24,"phases":139,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":96},"100627625","vasectomy-right-for-me-decision-support-tool-100627625","NCT07451067","\"Vasectomy: Right for Me?\" Decision Support Tool","Addressing Factors Related to Disparities in Vasectomy","Inclusion Criteria:\n\n* Are assigned male at birth\n* 21-55 years of age\n* Comfortable reading in English or Spanish\n* Live in the United States\n* Are considering vasectomy\n* Have not had a vasectomy\n\nExclusion Criteria:\n\n* Are not assigned male at birth\n* Are less than 21 or more than 55 years of age\n* Is not comfortable reading English nor Spanish\n* Do not live in the United States\n* Are not considering vasectomy\n* Have had a vasectomy\n* Once a racial or economic sub-group recruitment number has been reached, no other subjects fitting that ethnicity or income group will be enrolled.","MALE","21 Years","55 Years",{"count":138,"type":23},750,[56],"The goal of this trial is to learn if a web-based decision aid designed to provide evidence-based information about vasectomy and other birth control options helps improve users' decision-making about birth control. The main questions it aims to answer are:\n\n* Do people who use the decision aid have better knowledge about vasectomy?\n* Do people who use the decision aid have lower conflict with their decision?\n\nParticipants will:\n\n* Use the decision aid (if they are assigned to the intervention arm).\n* Answer survey questions about their knowledge, decision-making, interest in vasectomy, and healthcare navigation experiences.",[142,29,143,60],"Vasectomy","Contraception Behavior",[142,145],"Decision aid",{"date":120,"type":34},{"date":148,"type":34},"2026-06-20",{"date":150,"type":23},"2027-08",{"name":152,"class":41},"University of Pittsburgh",{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":105,"enrollmentInfo":160,"targetDuration":4,"studyType":24,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":42},"100616105","trial-of-the-mittin-intervention-to-improve-contraceptive-side-effect-counseling-and-follow-up-in-ethiopia-100616105","NCT07301281","Trial of the \"Mittin\" Intervention to Improve Contraceptive Side Effect Counseling and Follow-up in Ethiopia","Cluster Randomized Controlled Trial of the \"Mittin\" Intervention in Addis Ababa, Ethiopia","Inclusion Criteria:\n\n* Woman\n* Started or continued using hormonal contraceptive method or copper IUD on day of recruitment\n* Ages 15-49 years\n* Willing to provide phone number and receive follow-up phone call\n\nExclusion Criteria:\n\n* Not planning to live in Addis Ababa for the next eight months\n* Can not verbally communicate\n* Not willing to provide consent for the study",{"count":161,"type":23},2715,[56],"The goal of this clinical trial is to learn if the \"Mittin\" intervention can improve women's ability to manage their fertility in line with their preferences among women aged 15-49 using hormonal contraceptives or intrauterine devices and attending public health centers in Addis Ababa, Ethiopia. The main question it aims to answer is: Does the Mittin intervention increase preference-aligned fertility management, contraceptive method satisfaction, and preferred contraceptive method use among participants compared to standard care?\n\nResearchers will compare women's outcomes in health centers providing the Mittin intervention to women's outcomes in health centers that offer standard care to see if Mittin improves women's ability to act in line with their contraceptive preferences.\n\nParticipants will\n\n* Receive either standard contraception services (control arm) or enhanced services (intervention arm)\n* Participate in a survey at the beginning of the study\n* Participate in surveys 4 and 8 months later",[29,165],"Side Effects",{"date":120,"type":34},{"date":168,"type":34},"2026-02-23",{"date":170,"type":23},"2027-06",{"name":126,"class":41},{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":17,"sex":18,"minAge":180,"maxAge":76,"enrollmentInfo":181,"targetDuration":4,"studyType":24,"phases":183,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":4},"100647844","phase-3-evaluation-of-the-contraceptive-efficacy-and-safety-of-a-new-concentration-of-an-antiandrogenic-progestogen-combined-with-a-reduced-dose-estrogen-luna-100647844","NCT07714616","Evaluation of the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen (LUNA)","Phase III, Multicenter, Open-Label, Single-Arm Clinical Trial to Evaluate the Contraceptive Efficacy and Safety of a New Concentration of an Antiandrogenic Progestogen Combined With a Reduced-Dose Estrogen in Women of Childbearing Potential","LUNA","Inclusion Criteria:\n\n* Ability to voluntarily participate in the study and provide written informed consent (and assent, where applicable) before the performance of any study-specific procedures.\n* Biological female aged 14 to 45 years (inclusive) at the time of informed consent\u002Fassent.\n* Post-menarche for at least 1 year.\n* Regular menstrual cycles lasting 21 to 35 days documented during the 3 months prior to screening (for women not using hormonal contraception at screening).\n* Sexually active with a male partner, with a minimum frequency of one vaginal intercourse per month.\n* Male partner who is not known to be subfertile or infertile, has not undergone vasectomy, and is not known to be HIV-positive.\n* Male partner without homosexual intercourse within the previous 5 years without a subsequent negative HIV test and without shared needle use without a subsequent negative HIV test.\n* No history of investigated or diagnosed infertility.\n* Willing to refrain from using another contraceptive method during study treatment.\n* Adequate washout period from previous contraceptive methods:\n* ≥12 months for depot medroxyprogesterone acetate (DMPA, Depo-Provera®);\n\n  1. ≥6 months for monthly combined injectable contraceptives;\n  2. ≥3 months for subdermal implants or levonorgestrel-releasing intrauterine systems;\n  3. ≥2 spontaneous menstrual cycles for combined oral contraceptives or oral progestogens, or direct switch on the day following the last active tablet, according to the switcher classification.\n* Body mass index (BMI) ≥16 kg\u002Fm².\n* Participants aged 25 years or older must provide documentation of cervical cytology without clinically relevant abnormalities within the previous 18 months or a negative HPV DNA test within the previous 5 years.\n* Participants aged 40 years or older must provide documentation of bilateral mammography without findings suspicious for malignancy within the previous 24 months.\n* Willing and able to comply with study requirements, including use of the participant diary and attendance at scheduled visits.\n* Willing to use the investigational product as the primary contraceptive method during the 13 treatment cycles, without routine need for a backup contraceptive method.\n\nExclusion Criteria:\n\n* Confirmed or suspected pregnancy, or plans to become pregnant within the next 12 weeks.\n* Childbirth, abortion, or breastfeeding within the previous 3 months.\n* Personal history of cardiovascular disease, including myocardial infarction, stroke, coronary artery disease, peripheral arterial disease, venous thromboembolic disease (deep vein thrombosis or pulmonary embolism), arterial thromboembolic disease, or any condition that increases the risk of these disorders.\n* Known history of cardiomyopathy, heart failure, or clinically significant cardiac arrhythmia requiring continuous antiarrhythmic therapy.\n* Uncontrolled hypertension (systolic blood pressure \\>130 mmHg or diastolic blood pressure \\>80 mmHg) despite antihypertensive treatment, or requiring four or more classes of antihypertensive medications for adequate control.\n* Uncontrolled diabetes mellitus (history of HbA1c \\>7.0%) despite treatment with antihyperglycemic medications.\n* Uncontrolled dyslipidemia (history of LDL cholesterol \\>190 mg\u002FdL and\u002For triglycerides \\>500 mg\u002FdL) despite lipid-lowering therapy.\n* Known personal history of thrombophilia.\n* Current smoking of more than 5 cigarettes per day.\n* Any known condition that may worsen with hormonal treatment or interfere with study conduct or interpretation of results, including herpes gestationis, idiopathic jaundice during a previous pregnancy, otosclerosis, Sydenham's chorea, porphyria, or biliary disorders (including cholestasis or gallstones), or systemic lupus erythematosus.\n* History or current diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis), moderate or severe hepatic insufficiency, hemolytic uremic syndrome, headache with focal neurological symptoms, epilepsy, asthma requiring chronic oral corticosteroid use, multiple sclerosis, chorea minor, tetany, endometriosis, mastopathy, current premenstrual dysphoric disorder, sickle cell anemia, pancreatitis, diabetic vascular complications, or major depressive disorder.\n* Significant psychiatric condition or suicide risk, in the opinion of the investigator.\n* Hypersensitivity to any component of the investigational product.\n* History of alcohol and\u002For drug abuse.\n* Malignancy within the previous 5 years, except non-melanoma skin cancer, or any history of hormone-dependent malignancy or current suspicion of malignancy, including meningioma and hepatic tumors.\n* Organ transplantation within the previous 5 years or chronic disease with anticipated transplantation.\n* Use within the previous 90 days of medications known to interfere with cytochrome P450-mediated hepatic metabolism, including carbamazepine, phenytoin, primidone, oxcarbazepine, topiramate, rifampicin, ritonavir, or St. John's wort-containing products.\n* Use within the previous 90 days of direct-acting antiviral medications containing ombitasvir, paritaprevir, dasabuvir, or combinations of these agents.\n* Undiagnosed vaginal bleeding.\n* Abnormal breast examination findings or other clinically significant gynecological findings that, in the investigator's opinion, could worsen with oral contraceptive use.\n* Participant living with HIV infection or with a history of unresolved hepatitis B or hepatitis C infection.\n* Participation in another clinical trial within the previous 12 months, unless the investigator considers that direct benefit to the participant may be expected.\n* Any other clinical condition or laboratory abnormality that, in the investigator's opinion, makes the participant unsuitable for study participation.","14 Years",{"count":182,"type":23},1600,[184],"PHASE3","This study is a Phase III, multicenter, open-label, single-arm clinical trial designed to evaluate the contraceptive efficacy and safety of a new formulation containing N0999 in women of childbearing potential. Approximately 1,600 post-menarche women aged 14 to 45 years who are candidates for systemic hormonal contraception are expected to be enrolled.\n\nAll participants will receive the investigational product, consisting of N0999 administered in a 24+4 regimen. Each treatment cycle consists of 24 active tablets followed by 4 inactive tablets. Participants will receive treatment for 13 consecutive 28-day cycles, corresponding to approximately 52 weeks of treatment. Total study participation, including screening and follow-up, is expected to be approximately 58 weeks.\n\nThe primary objective of the study is to evaluate contraceptive efficacy over 13 treatment cycles using the Pearl Index in participants aged 35 years or younger. Secondary objectives include assessing the Pearl Index in the overall study population and in participants older than 35 years, evaluating the method-failure Pearl Index based on correct and consistent use, and estimating cumulative pregnancy rates using Life Table Analysis.\n\nAdditional objectives include evaluating cycle control, including withdrawal bleeding, intermenstrual spotting, amenorrhea, and bleeding duration, as well as participant satisfaction with study treatment. Exploratory assessments of clinical and laboratory signs of hyperandrogenism will also be performed.\n\nThe safety and tolerability of the investigational product will be evaluated throughout the study by monitoring adverse events, serious adverse events, adverse events of special interest, safety-related discontinuations, clinically relevant findings, and laboratory assessments. An Independent Data and Safety Monitoring Committee will oversee participant safety during the trial.\n\nParticipants who wish to become pregnant after completing treatment may participate in an additional exploratory follow-up period of up to 12 months to characterize the return of spontaneous menstruation",[29],"2026-07-20",{"date":118,"type":34},{"date":190,"type":23},"2027-05-31",{"date":192,"type":23},"2030-05-31",{"name":194,"class":195},"Eurofarma Laboratorios S.A.","INDUSTRY",{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":206,"phases":4,"briefSummary":207,"conditions":208,"keywords":213,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":42},"100632658","pharmacokinetic-study-of-long-acting-antiretrovirals-and-contraceptives-in-hiv-100632658","NCT07516548","Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptives in HIV","Pharmacokinetic Study of Long-acting Antiretrovirals and Contraceptive Options in HIV Prevention","PHARAOH","Parent Tshireletso Study Inclusion Criteria:\n\n1. Female 18 years of age or older and willing and able to provide an informed consent\n2. \\\u003C 14 days after delivery (calendar day of birth = day 0)\n3. Negative HIV screening test (conducted at the time of enrolment)\n4. Female \\\u003C30 years old or has had \\\u003C 3 prior pregnancies (Gravida 1, 2, or 3 including this pregnancy)\n5. Plan to stay and receive postpartum and pediatric care in the Gaborone or Molepolole region for 24 months\n\nParent Tshireletso Study Exclusion Criteria\n\n1. Receiving carbamazepine, phenobarbital, phenytoin, oxycarbazepine, rifampin, rifabutin, rifapentine, systemic dexamethasone (\\>1 dose oral\u002FIV), or St. John's wort\n2. Suspected to have, recently diagnosed with, or on treatment for TB (due to interaction with rifampicin)\n3. Previous hypersensitivity reaction to CAB or other INSTI\n4. Unstable medical or psychiatric condition making it unlikely they will be able to adhere to injections every 2 months\n5. Plan for pediatric and post-partum care outside the government system (private clinics)\n6. Inflammatory skin condition that compromises the safety of the intramuscular injection\n7. Weight \\\u003C35kg\n\nParent Doris Duke Study Inclusion Criteria Post-partum females included;\n\n1. if HIV-uninfected or unknown HIV status, willing to be tested for HIV\n2. if HIV-infected, documented to be on DTG as part of an antiretroviral treatment regimen\n3. maternal age \\>18 years,\n4. ability to speak English or Setswana\n5. intend to be available for follow up in Molepolole, Gaborone or Mochudi for 18 months post-delivery\n6. have access to a cell phone (including phone of friend or relative)\n\nParent Doris Duke Study Exclusion Criteria Post-partum females excluded if\n\n1. did not attend antenatal care or were not included in Tsepamo surveillance\n2. maternal age \\\u003C18,\n3. females who do not speak English or Setswana,\n4. unable or unwilling to give consent\n5. will not be able to attend follow up at a study site\n6. do not have access to any cell phone for follow up calls\n\nAdditional Inclusion Criteria for this PK Study\n\n1. For DMPA and ETG implant groups, intends to initiate or continue use of DMPA or ETG implant for at least another three or six months, respectively,\n2. For the CAB-LA groups, have received at least three consecutive CAB injections on time, including the one administered concurrently while starting a contraceptive method,\n3. Willing to undergo phlebotomy every 4 weeks for the duration of the sub-study period Additional Exclusion Criteria for this PK Study\n\n1\\) Use or anticipated use of nicotine-containing products (e.g., cigarettes or hookahs) known to interact with CAB-LA for the duration of the sub-study period 2) Use within the previous 90 days, current use, or planned future concomitant use of other hormonal contraceptives, including oral contraceptive methods 3) BMI≥35 4) Has any of the following laboratory abnormalities within the last year:\n\n1. Serum ALT\\>5x ULN at the time of screening,\n2. Serum creatinine \\>2.5x ULN at the time of screening. 5) Has any other condition that, in the opinion of the sub-study PI\u002Fdesignee, would preclude informed consent, make study participation unsafe, or complicate interpretation of study outcome 6) HIV infected females on the Doris Duke parent study",{"count":205,"type":23},105,"OBSERVATIONAL","This study is being done to understand how long-acting injectable cabotegravir (CAB-LA) used for HIV pre-exposure prophylaxis (PrEP) and hormonal contraceptive methods affect each other when used at the same time. Women who are already using CAB-LA or not using PrEP will choose to join one of several groups based on whether they use injectable contraceptive (IM DMPA), an etonogestrel implant, or no hormonal contraceptive. Participants will have study visits every 4 to 12 weeks for up to 12 or 24 weeks after starting a contraceptive method to collect blood samples and measure levels of CAB-LA and hormone concentrations. The study will compare these levels to see if taking CAB-LA changes hormone concentrations or if using hormonal contraception changes CAB-LA drug levels. Safety, side effects, satisfaction, and continuation of CAB-LA PrEP and contraceptive methods will also be evaluated.",[209,29,210,211,212],"HIV Infections","Drug-drug Interaction","PrEP","Long-acting Injectable Cabotegravir for PrEP",[214,215,216,217,218,211,219],"Adolescent girls and young women","Injectable cabotegravir","Botswana","Long-acting injectable cabotegravir","Pharmacokinetic study","HIV prevention","2026-07-19",{"date":118,"type":34},{"date":223,"type":23},"2026-08-01",{"date":225,"type":23},"2026-12-31",{"name":227,"class":41},"University of Alabama at Birmingham",{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":76,"enrollmentInfo":235,"targetDuration":4,"studyType":24,"phases":237,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":96},"100541780","phase-4-oral-contraceptive-pill-ocp-pharmacogenomics-100541780","NCT06334315","Oral Contraceptive Pill (OCP) Pharmacogenomics","Influence of Genetics Variants on the Pharmacokinetics and Pharmacodynamics of Combined Oral Contraceptive Pill Users","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Female, aged 18-45 years old\n4. In good general health as evidenced by medical history and no need for regular intensive medical interventions (e.g., inpatient admissions, surgical treatments). The Principal Investigator will be responsible for determining good general health for potential participants with complicated medical histories.\n5. Ability to take oral medication and be willing to adhere to the oral contraceptive pill (DSG\u002FEE) regimen\n6. Body-mass index ≥18.5kg\u002Fm2\n7. Willing to abstain from medications and supplements known to induce\u002Finhibit CYP3A (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort) during the study\n8. Normal blood pressure measurement at study screening\n9. Negative urine pregnancy test at study screening\n\nExclusion Criteria:\n\n1. Currently taking any known CYP3A inducers\u002Finhibitors (e.g., rifampin, carbamazepine, ketoconazole, St. John's wort)43\n2. Any medical conditions that affect liver function (e.g., hepatitis, cirrhosis)\n3. Contraindications to estrogen-containing contraception (based on category 3 or 4 recommendations in the CDC MEC guidelines42)\n\n   1. Current breast cancer or personal history of breast cancer\n   2. Severe decompensated cirrhosis\n   3. Personal history of deep venous thrombosis or pulmonary embolism\n   4. Recent major surgery with prolonged immobilization\n   5. Diabetes with nephropathy, retinopathy, neuropathy, or other vascular disease\n   6. Current gallbladder disease\n   7. Migraine headaches with aura\n   8. History of malabsorptive bariatric surgery\n   9. History of cholestasis due to past oral contraceptive pill use\n   10. Personal history of hypertension\n   11. Personal history of ischemic heart disease\n   12. Known thrombogenic mutations\n   13. Personal history of focal nodular hyperplasia of the liver, hepatocellular adenoma, or malignant hepatoma\n   14. Multiple sclerosis with prolonged immobility\n   15. History of peripartum cardiomyopathy\n   16. Current tobacco smoker and age ≥35 years\n   17. History of complicated solid organ transplantation\n   18. Personal history of stroke\n   19. Personal history of superficial venous thrombosis\n   20. Systemic lupus erythematosus with positive or unknown antiphospholipid antibodies\n   21. Complicated valvular heart disease\n   22. Current use of fosamprenavir or lamotrigine\n4. Use of injectable contraceptive method within 6 months or current use of an ENG implant\n5. Childbirth within 6 months",{"count":236,"type":23},700,[26],"The goal of this clinical trial is to evaluate how differences in specific parts of our DNA can influence how individual bodies break down the hormones contained within oral contraceptive pills, which could affect how well these birth control pills work to prevent pregnancy. The investigators are also interested in exploring how these differences in our DNA can also explain why patients taking the exact same formulation of birth control pill will experience very different side effects. The main questions it aims to answer are:\n\n* Do individuals with the CYP3A7\\*1C variant have increased metabolism of both desogestrel and ethinyl estradiol when taking a combined oral contraceptive pill?\n* Do individuals with the CYP3A7\\*1C variant experience higher rates of breakthrough ovulation while taking a desogestrel\u002Fethinyl estradiol combined oral contraceptive pill?\n* What novel genetic loci are associated with alterations in steroid hormone pharmacokinetics and pharmacodynamics among a larger cohort of combined oral contraceptive pill users?\n\nParticipants will take a specific formulation of combined oral contraceptive pill (desogestrel\u002Fethinyl estradiol) and undergo the following procedures:\n\n* Blood draw to measure the amount of progestin and estrogen in their system from the combined oral contraceptive pill\n* Questionnaires to assess side effects possibly caused by the combined oral contraceptive pill\n* Blood draw to measure endogenous hormone levels and biomarkers that may be affected by the combined oral contraceptive pill\n* A transvaginal ultrasound to measure any ovarian follicles (optional procedure)",[29,240],"Pharmacogenomic Drug Interaction","2026-07-14",{"date":243,"type":34},"2026-07-16",{"date":245,"type":34},"2024-10-29",{"date":247,"type":23},"2028-05",{"name":95,"class":41},{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":206,"phases":4,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":268,"locationsCount":42},"100636523","validation-of-effectiveness-on-naturalcycles-users-100636523","NCT07566793","Validation of Effectiveness on NaturalCycles Users","A Prospective Observational Study on the Contraceptive Effectiveness of the Natural Cycles Application (The VENUS Study)","VENUS","Inclusion Criteria:\n\n* Wants to avoid pregnancy for 13 cycles.\n* Is willing to rely solely on Natural Cycles as their sole contraception method for 13 cycles.\n* Is not currently using permanent contraceptive methods, such as sterilization (of either the user or their partner), or hormonal methods, such as the hormonal contraceptive implant or IUD.\n* Has an intact uterus, both ovaries and both fallopian tubes to the best of their knowledge.\n* Has an average cycle length between 21 and 35 days. The user anticipates heterosexual intercourse at least once a month in the next year.\n* Is willing to enter data on a daily basis and perform pregnancy tests as requested by protocol.\n* Is willing to complete a satisfaction survey at the end of her study participation.\n\nExclusion Criteria:\n\n* Has EU-citizenship\n* Has had a Depo-Provera injection in the last 10 months or has had less than three consecutive, spontaneous menstrual cycles since their last injection.\n* Has had less than three consecutive, spontaneous menstrual cycles after removing a hormonal implant.\n* Has had less than three consecutive, spontaneous menstrual cycles after the end of a pregnancy.\n* Has had less than three consecutive, spontaneous menstrual cycles since she last breastfed.\n* Has (or partner has) known fertility issues, such as infertility and sterilization, or have been advised by a healthcare professional that they may have difficulty conceiving for any reason.\n* Has a medical condition possibly impacting fertility, i.e. endometriosis, a history of Pelvic Inflammatory Disease (PID), significant uterine fibroids or adenomyosis, or another diagnosed medical condition that they have been told affects fertility.\n* Is regularly taking one of the following prescribed pharmaceutical medications known to be teratogenic (i.e., a medication that can cause birth defects):\n\nIsotretinoin (like Accutane, Absorica, Claravis, or Myorisan) for severe acne Valproic acid or divalproex sodium (like Depakote, Depakene, or Topamax) for seizures (epilepsy), migraines, or bipolar disorder Methotrexate (Trexall, Rheumatrex) or leflunomide (Arava) for autoimmune conditions ACE Inhibitors (like Lisinopril, Enalapril) or Angiotensin II Receptor Blockers (ARBs) (like Losartan, Valsartan) for high blood pressure or heart conditions Warfarin (Coumadin, Jantoven) for blood clot prevention","35 Years",{"count":259,"type":23},2000,"The goal of this observational study is to measure the effectiveness of the Natural Cycles digital birth control application at preventing pregnancy in sexually active women aged 18 to 35 with no known history of infertility. The main questions it aims to answer are:\n\n* What is the pregnancy rate of the application over one year, for all users?\n* What is the pregnancy rate of the application over one year, for users who follow the application's instructions perfectly?\n\nParticipants will:\n\n* Use the Natural Cycles application for birth control for up to one year.\n* Log information about daily sexual activity in the app.\n* Complete a questionnaire at the beginning and end of their participation.\n* Perform urine pregnancy tests (provided by mail) upon entry to the study, at the start of every cycle during the study, and upon exit from the study.",[29],"2026-06-30",{"date":264,"type":34},"2026-07-01",{"date":266,"type":34},"2026-04-28",{"date":38,"type":23},{"name":269,"class":195},"Natural Cycles",{"id":271,"slug":272,"hasResults":12,"nctId":273,"briefTitle":274,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":17,"sex":277,"minAge":19,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":206,"phases":4,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":42},"100638066","dynamic-decision-support-for-integrating-prep-in-clinics-for-young-people-in-alabama-and-botswana-100638066","NCT07597824","DYnamic decisioN Support for IntegrAting PrEP in Clinics for Young People in Alabama and Botswana","DYNAMIC PrEP","Group 1\n\n* Inclusion for Alabama site:\n\n  * 18 years of age or older\n  * Currently using or eligible for PrEP\n* Inclusion for Botswana site:\n\n  * 18 years of age or older\n  * Participated in the parent Tshireletso study in Botswana\n* Exclusion for both sites:\n\n  * Under the age of 18\n  * HIV positive\n\nGroup 2\n\n* Inclusion for both sites:\n\n  * 18 years of age or older\n  * Currently working as PrEP providers or clinic administrators at outpatient clinics\n* Exclusion for both sites:\n\n  * Under the age of 18\n\nGroup 3\n\n* Inclusion for both sites:\n\n  * 18 years of age or older\n  * Currently working as policy makers or program leaders at outpatient clinics\n* Exclusion for both sites:\n\n  * Under the age of 18","ALL",{"count":279,"type":23},1000,"This study evaluates strategies to improve access to HIV prevention through the integration of pre-exposure prophylaxis (PrEP) into existing healthcare settings, rather than limiting delivery to specialty clinics. The study addresses barriers to PrEP uptake, including limited awareness, stigma, and restricted access, and recognizes that availability alone may not ensure initiation or sustained use.\n\nThe study includes two components. First, a longitudinal cohort of current PrEP users will be followed to assess changes in access, preferences, and PrEP use over time in real-world settings. Second, a dynamic decision-support toolkit will be developed and evaluated to support patients and providers in PrEP-related decision-making. The toolkit will include patient- and provider-facing components to support clinical decision-making, improve risk understanding, and facilitate integration of PrEP into routine healthcare. The toolkit will be refined and beta-tested in selected healthcare facilities in Botswana and Alabama.",[209,29,211],[283,211,284,216,285],"HIV adherence","young adults","Alabama","2026-06-23",{"date":288,"type":34},"2026-06-25",{"date":290,"type":23},"2026-06",{"date":292,"type":23},"2031-12",{"name":227,"class":41},{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":301,"enrollmentInfo":302,"targetDuration":4,"studyType":24,"phases":304,"briefSummary":305,"conditions":306,"keywords":309,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":4},"100644200","safety-of-a-contraceptive-copper-vaginal-ring-100644200","NCT07666997","Safety of a Contraceptive Copper Vaginal Ring","Prospective Elavulation of the Safety of a Novel Copper Vaginal Contraceptive Ring (CVR)","Inclusion Criteria:\n\n* Biological female\n* Age \\>18\n* Premenopausal women\n* Regular, normal, cyclic menses, with a usual length of 21 to 35 days\n* Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol\n\nExclusion Criteria:\n\n* Use of oral contraceptives, Copper-IUD, hormonal-IUD, another intravaginal contraceptive device, or any other method of female birth control within 3 months prior to study enrollment\n* Postmenopausal\n* Biological male\n* Positive urine pregnancy test at screening visit\n* Use of hormone therapy; injectable within the past 6 months; implantable within the past 3 months;\n* Presence of a vaginal\u002Fcervical\u002Futerine anomaly or a diagnosed pathology that effects the vaginal cavity and may impair the ability to safely insert\u002Fremove a vaginal ring.\n* The presence of certain conditions of relevance to vaginal ring use, such as cervicitis, vaginitis or bleeding cervical erosion; lichen sclerosis, lichen planus or vaginismus; Papanicolau (PAP) grade III-V cervical smear result; prolapse of uterine cervix, cystocele and\u002For rectocele; severe or chronic constipation, dyspareunia or other coital problems; .\n* History or current diagnosis of any of the following:\n* gynecological cancer\n* fibroids\n* polycystic ovary syndrome\n* Past exposure to radiation therapy to the pelvis, or planned radiation therapy to the pelvis during the study;\n* Current diagnosis of a sexually transmitted disease;\n* Wilson's Disease;\n* Known allergy to metal or silicone\n* Had an abortion or breastfeeding within 2 months before the start of the trial;\n* Presence of a significant medical condition or health concern that, in the opinion of the investigator, may impact the patient's safety or the study's outcomes;\n* A condition that, in the opinion of the investigator, precludes the patient from being able to provide informed consent;\n* Inability or unwillingness to refrain from using a tampon\u002Fmenstrual cup for the duration of the study.\n* Known inability to tolerate products\u002Fdevices in the vagina (i.e., tampons, menstrual cups, vaginal rings, etc.)","50 Years",{"count":303,"type":23},8,[56],"Many birth control options today come with unwanted side effects or risks. Hormonal methods can affect both mental and physical health, while devices like copper IUDs carry risks such as uterine perforation or infection. This study is testing a new option: a copper vaginal ring (CVR) - a non-hormonal, non-invasive contraceptive that can be self-inserted, similar to a other vaginal rings like NuvaRing or Annovera.\n\nThe main goal of this study is to assess whether the copper vaginal ring is safe to use. Researchers will also look at how comfortable and easy it is to use, whether participants follow the instructions, and how much copper accumulates in cervical mucus and vaginal fluid during use.\n\nThe study will enroll 8 women of childbearing age. Participants wear the ring continuously for 28 days, inserting it on Day 5 of their menstrual cycle. Over the course of the study, participants will attend 8 in-person clinic visits, which include pelvic exams, vaginal swabs, blood draws, and cervical mucus collection. On the day the ring is removed (Day 28), small tissue samples (biopsies) are taken from the vagina and uterine lining. At the end of the study, participants will complete a short survey about their experience with the ring.",[29,307,308],"Birth Control","Pregnancy Prevention",[310,311],"Non-hormonal","Vaginal ring","2026-06-19",{"date":314,"type":34},"2026-06-24",{"date":316,"type":23},"2026-10-01",{"date":318,"type":23},"2027-04-30",{"name":320,"class":195},"Elle, MD Biotechnologies Inc.",{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":277,"minAge":19,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":24,"phases":330,"briefSummary":331,"conditions":332,"keywords":342,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":361,"locationsCount":363},"100509219","improving-alcohol-and-substance-use-care-access-outcome-equity-during-the-reproductive-years-100509219","NCT05910580","Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years","Improving Alcohol and Substance Use Care Access, Outcomes, and Equity During the Reproductive Years: A Type 1 Hybrid Trial in Family Planning Clinics","Inclusion Criteria:\n\n* Over the age of 18 years\n* U.S. residing\n* Have internet access (own a computer or smart phone)\n* Screen positive to one or more risky alcohol and substance use behaviors as determined by our standardized abbreviated instruments\n\nExclusion Criteria:\n\n* Not capable of communicating (reading, speaking, writing) in English or Spanish",{"count":329,"type":23},400,[56],"The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic.\n\nThe main questions it aims to answer are:\n\n* Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing?\n* Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity?\n* Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)?\n\nParticipants will receive in-person and telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months.\n\nResearchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.",[333,334,335,336,337,338,29,339,340,341],"Alcohol-Related Disorders","Substance-Related Disorders","Mental Health","Reproductive Health","Sexual Health","Sexually Transmitted Diseases","Maternal Health","Pregnancy","Women's Health",[343,344,345,346,347,348,349,350,351,352,353,354],"Implementation Science","Mass Screening","Motivational Interviewing","Referral and Consultation","Quality of Health Care","Early Medical Intervention","Family Planning Services","Primary Health Care","Reproductive Health Services","Telemedicine","Preconception Care","Young Adult","2026-06-12",{"date":357,"type":34},"2026-06-15",{"date":359,"type":34},"2025-07-03",{"date":190,"type":23},{"name":362,"class":41},"Emory University",4,{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":76,"enrollmentInfo":371,"targetDuration":4,"studyType":24,"phases":373,"briefSummary":374,"conditions":375,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":42},"100553095","patient-clinical-linkages-to-improve-trust-and-engagement-in-postpartum-healthcare-100553095","NCT06481631","Patient-clinical Linkages to Improve Trust and Engagement in Postpartum Healthcare","Empowering Women for Postpartum Care and Reproductive Health in Mississippi Delta","Inclusion Criteria:\n\n* Identified as high risk pregnancy\n* Postpartum mothers\u002Fparents 18-45 years\n* Resident of the one of 5 target counties (Washington, Bolivar, Scott, Humphreys, and Carroll)\n* Maternal healthcare providers in target counties\n* Maternal community health leaders\n\nExclusion Criteria:\n\n* not identified as high risk pregnancy\n* 18 years of age postpartum\n* cesarean birth\n* non-resident of the 5 target counties",{"count":372,"type":23},250,[56],"Maternal mortality in the United States is higher than in peer nations and has not decreased since 1990. Beyond mortality, severe maternal mortality impacts far too many women. Not only are these high rates alarming, but notable racial\u002Fethnic and socioeconomic disparities exist. These inequities are highly regional, with women living in the rural southeast part of the United States, including the Mississippi Delta, having the highest rates of maternal mortality and morbidity. Unfortunately, these disparities have proven to be stubbornly resistant to interventions, necessitating an innovative multifaceted approach focused on community practice, building trust, and prioritizing patient voices. To meet this need, this proposal aims to establish the Mississippi Delta Research Center of Excellence for Maternal Health with the goal of addressing preventable maternal mortality, decreasing severe maternal morbidity, and promoting maternal health equity in partnership with the Mississippi Delta community. This patient-clinical linkages intervention study will evaluate the effectiveness of a multilevel and multisector communication and health literacy strategy to increase trust and engagement in postpartum healthcare among women in the Mississippi Delta, with a specific focus on Black women, their families, and their communities.\n\nThese research projects both have the overarching goal of partnering with the community to determine and meet the needs of pregnant and postpartum women in the Mississippi Delta and address the disparities within maternity health and health care outcomes.",[376,377,378,379,29,380,381],"Family Dynamics","Trust in Healthcare System","Family Structure","Health Literacy","Maternal Behavior","Postpartum Mood Disturbance","2026-06-04",{"date":384,"type":34},"2026-06-08",{"date":386,"type":34},"2025-06-01",{"date":388,"type":23},"2030-06-30",{"name":390,"class":41},"Jackson State University",{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":206,"phases":4,"briefSummary":401,"conditions":402,"keywords":406,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":416,"leadSponsor":418,"locationsCount":42},"100633290","female-reproductive-health-in-canadian-armed-forces-100633290","NCT07524764","Female Reproductive Health in Canadian Armed Forces","Female Reproductive Health in Canadian Armed Forces: Experience, Access to Care, and Support","BEARH2025","Inclusion Criteria (part 1):\n\n* Female (biological sex)\n* Aged at least 18 years old\n* Completed Basic Military Qualification (including Regular Forces, Reserve Forces (Class A, B, or C), Canadian Rangers, COATS instructors, and survivors of the LGBT Purge whose official records of service have been changed to reflect the nature of their discharge)\n\nInclusion Criteria (part 2):\n\n* Female (biological sex)\n* Aged at least 18 years old\n* Completed Basic Military Qualification (including Regular Forces, Reserve Forces (Class A, B, or C), Canadian Rangers, COATS instructors, and survivors of the LGBT Purge whose official records of service have been changed to reflect the nature of their discharge)\n* Have experienced a reproductive health issue while serving in the CAF\n\nInclusion Criteria (part 3):\n\n* Healthcare providers (CAF Health Services, public servant, civilian) who has treated female patients who are actively serving and\u002For Veterans of the CAF in the past 5 years.\n* Stakeholders who are involved in supporting reproductive health of female members of the CAF and\u002For Veterans.\n* Policymakers who are involved in supporting reproductive health of female members of the CAF and\u002For Veterans.",{"count":400,"type":23},1121,"This is a mixed-method study aimed at gathering new evidence on reproductive health among female service members in the Canadian Armed Forces (CAF). Reproductive health includes four primary domains: contraception; undesired reproductive outcomes (including unintended pregnancy, adverse pregnancy outcomes, and infertility); assisted reproductive care; and pelvic floor dysfunctions. Additional factors that may influence reproductive outcomes will also be explored, including gynecological health (including but not limited to menstrual health, menopause, breast injury, sexually transmitted and blood-borne infections) as well as physical and psychological health (including but not limited to repetitive strain injuries, depression, and post-traumatic stress disorder). Evidence gathered on reproductive health issues will include, but not limited to, the lived experiences (occurrence), associated risk factors, access to care, including barriers and facilitators, service utilization, and career-related impacts among actively serving members and Veterans of the CAF. These will inform the development of recommendations and support services aimed at improving reproductive health care within the CAF. This project is divided into 3 convergent parts:\n\nPart 1: An online pan-Canadian survey that will achieve a minimum total sample of 1067 participants.\n\nPart 2: Semi-structured individual interviews (open-ended questions) will be conducted with female CAF members and Veterans who have experienced at least one reproductive health issues. A total of 30 participants are estimated to be required to achieve data saturation across the four primary domains.\n\nPart 3: Semi-structured group discussion (open-ended questions) will be conducted with healthcare providers, who have experience with treating female reproductive health issues in CAF members, as well as stakeholders and policymakers involved in supporting female members of the CAF\u002FVeterans. A total of 24 healthcare providers\u002Fstakeholders\u002Fpolicymakers will form 3 group discussion (8 participants\u002Fgroup).\n\nFor all 3 parts, efforts in recruitment will be made to ensure representation across CAF elements, minority groups, and native language (French and English).",[340,403,404,29,405,341],"Pelvic Floor Dysfunction","Military Personnel","Infertility",[407,408,340,405,409,29,410,411],"Reproductive health issue","Women's health","Pelvic floor dysfunction","Canadian Armed Forces","Military personnel","2026-05-19",{"date":414,"type":34},"2026-05-22",{"date":412,"type":34},{"date":417,"type":23},"2026-12-15",{"name":419,"class":41},"Université de Sherbrooke",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":76,"enrollmentInfo":427,"targetDuration":4,"studyType":24,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":438,"locationsCount":42},"100572013","phase-3-levonorgestrel-piroxicam-versus-ulipristal-acetate-for-emergency-contraception-100572013","NCT06727734","Levonorgestrel-piroxicam Versus Ulipristal Acetate for Emergency Contraception","Levonorgestrel-piroxicam Combination Versus Ulipristal Acetate for Emergency Contraception: a Randomised Double-blind Controlled Trial","Inclusion Criteria:\n\n1. women aged 18-45 years;\n2. requesting an oral EC within 120 hours of a single or the first act of unprotected intercourse in the current menstrual cycle;\n3. available for follow-up over the next 6 weeks.\n\nExclusion Criteria:\n\n1. post-abortion or postpartum and period have not yet returned,\n2. being on the following drugs currently: anticoagulants, cyclosporine, tacrolimus, corticosteroids, lithium, serotonin reuptake inhibitors (SSRIs), quinolones\n3. having unprotected intercourse in this cycle more than 120 hours before attending the clinic,\n4. being found pregnant at the time of presentation,\n5. breastfeeding,\n6. having been sterilized (or partner having been sterilized) or having intrauterine contraceptive device in-situ,\n7. uncertain about the date of the last menstrual period,\n8. having used a hormonal contraceptive (including EC), progestogen-containing medication or NSAID in the recent one week,\n9. having history of asthma, urticaria or other allergic reactions to piroxicam, aspirin or other NSAIDs,\n10. having history of ischaemic heart disease, heart failure, hypertension, cerebrovascular disease or kidney failure requiring dialysis\n11. having history of peptic ulcer disease and\u002For gastrointestinal bleeding.",{"count":428,"type":23},980,[184],"The goal of this clinical trial is to compare the failure rate of the levonorgestrel (LNG)-piroxicam combination regimen versus ulipristal acetate (UPA) as emergency contraception (EC). The main questions it aims to answer are:\n\n1. whether the LNG-piroxicam combination regimen has a lower failure rate than UPA for EC;\n2. whether the LNG-piroxicam combination regimen has a higher percentage of pregnancies prevented than UPA for EC\n3. whether there is any difference in the change in the subsequent menstrual cycle and adverse effect profile between the two regimens\n\nParticipants will:\n\n1. Take a single dose of either (i) LNG 1.5 mg plus piroxicam 40 mg and a placebo tablet resembling UPA, or (ii) UPA 30 mg plus placebo tablets resembling LNG and piroxicam.\n2. Have a blood test for serum LH, oestradiol an progesterone.\n3. Keep a diary of their vaginal bleeding episodes, adverse effects symptoms, any further acts of intercourse and the type of contraception used.\n4. Have a follow-up either in person by phone about 1-2 weeks after the next expected menstruation.\n5. If normal menstrual bleeding has not occurred by that time, a pregnancy test will be carried out.",[29],"2026-05-11",{"date":434,"type":34},"2026-05-14",{"date":436,"type":34},"2025-01-18",{"date":93,"type":23},{"name":439,"class":41},"The University of Hong Kong",{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":447,"targetDuration":4,"studyType":24,"phases":449,"briefSummary":450,"conditions":451,"keywords":452,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":454,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":462},"100525858","contraceptive-efficacy-study-of-ovaprene-100525858","NCT06127199","Contraceptive Efficacy Study of Ovaprene","A Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Ovaprene","Inclusion Criteria:\n\n* Sexually active people assigned female at birth, at risk for pregnancy and desiring contraception.\n* General good health, by subject history and per investigator judgement\n* Age 18 through 40 years, inclusive; approximately 66 subjects \\>35 years old at visit 2 will be the Enrolled-Eligible Population\n* In a relationship with a person assigned male at birth who meets eligibility criteria below.\n\n  --At least 18 years old, not known to be subfertile or infertile\n* Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days, without heave bleeding that lasts longer than 5 days\n* Be willing to stop their current method of contraception (with the exception of condoms) before Visit 2. Participants must experience at least one subsequent menstrual bleed before inserting Ovaprene. Participants using injectable contraception must be at least 9 months post their last dose at screening and have experienced at least 2 subsequent regular menstrual bleeds that were part of cycles of 21-35 days. After stopping their current method of contraception, subjects must either abstain fro vaginal sex or use condoms before inserting their first Ovaprene\n* Not be actively desiring pregnancy for at least 13 months and be willing to accept an unknown risk of pregnancy\n* Expect to engage in at least 4 acts of heterosexual vaginal intercourse per cycle during the study.\n* Be willing to only use Ovaprene as the sole method of contraception over the course of the study\n* Agree not to participate in any other clinical trials during the course of the study\n* Be willing and able to comply with study procedures and to return to the clinic for scheduled follow-up visits\n* Microbiota\u002Finnate immunity and colposcopy subsets only:\n\n  * Be willing to avoid vaginal sex and using tampons and other intravaginal products for 48 hours prior to clinic visits; and be willing to comply with subset procedures\n\nExclusion Criteria:\n\n* Currently pregnant and\u002For have a positive urine pregnancy test at screening.\n* Have an allergy to the ingredients in Ovaprene\n* Have a history of toxic shock syndrome\n* Have a history of hereditary hemochromatosis\n* Be breastfeeding an infant\n* Have a history suggestive of infertility, defined as any of the following: known history of ectopic pregnancy or other fertility problem; sterilization\u002Fpermanent contraception; endometriosis or hospitalization for pelvic inflammatory disease (PID) unless subject has had a subsequent spontaneous intrauterine pregnancy; or use of medications that could cause subfertility such as gonadotropin-releasing hormone agonists\n* Currently have postcoital bleeding\n* Have contraindications to pregnancy (medical condition) or chronic use of medications contraindicated in pregnancy\n* Have a history of clinically significant uterine prolapse, cystocele, or rectocele that has required surgical intervention or pessary use\n* Positive human immunodeficiency virus (HIV) test at screening\n* Have exclusionary results on human papilloma virus (HPV) screening\u002Fcytology (subjects\\>\u002F=21 years old) at screening or require treatment or follow-up for an abnormal Pap smear or HPV test that would be needed during the study.\n* Have had a vaginal or cervical biopsy within 1 month or vaginal surgery within the 3 months prior to screening\n* Known current drug or alcohol abuse which, in the opinion of the investigator, could impact study compliance\n* Have previously been included in the Enrolled-Eligible Population\n* Is a direct employee or immediate family member of the Sponsor company, site Investigators or study staff\n* Have taken any investigational drug or used any investigational device within the 30 days prior to screening\n* Have a history of any severe acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or study treatment administration or could interfere with the interpretation of trial results\n* Microbiota\u002Finnate immunity subset only:\n\n  --systemic use in the last 2 weeks prior to screening or anticipated use during the study of antibiotics (other than those used to treat urinary tract infection (UTI), candidiasis, or bacterial vaginosis(BV) diagnosed at Visit 1) or antivirals;\n* If male partner has or is suspected to have had an HIV infection or other sexually transmitted infection\n* if male partner has a known sensitivity or allergy to the ingredients in Ovaprene\n* If male partner has previously participated in this study or has taken any investigational drug or used any investigational device within 30 days prior to the female subject's screening\n* If the male partner has a history of any severe acute or chronic medical or psychiatric condition that could increase the risk associated with trial participation or could interfere with the interpretation of trial results.",{"count":448,"type":23},656,[56],"This will be a multi-center, single arm, open-label study of Ovaprene, a non-hormonal intravaginal ring, to investigate the contraceptive effectiveness, safety and acceptability of Ovaprene.",[29],[453,310],"Device","2026-05-07",{"date":432,"type":34},{"date":457,"type":34},"2023-12-19",{"date":459,"type":23},"2027-09",{"name":461,"class":195},"Daré Bioscience, Inc.",27,{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":469,"targetDuration":4,"studyType":206,"phases":4,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":480,"locationsCount":42},"100586001","influences-of-long-acting-reversible-contraceptives-on-iron-status-and-physiological-responses-to-extreme-environments-in-women-100586001","NCT06909695","Influences of Long-acting Reversible Contraceptives on Iron Status and Physiological Responses to Extreme Environments in Women","Inclusion Criteria:\n\n* • Females, age 18-40 y\n\n  * Females taking monophasic oral contraceptives or utilizing implantable contraception (intrauterine device, implantable bar) for at least one year, and be at least one year removed from the removal end point (e.g. before year 4 for a 5-year IUD)\n  * In good health as determined by OMSO (Office of Medical Support and Oversight)\n  * Passed most recent Army Combat Fitness Test (ACFT) (military volunteers only) or exercise at least 2 times per week (civilian volunteers)\n  * Willing to not drink alcoholic beverages for 24 hours before each testing session\n  * Willing to not consume caffeine 12 hours prior to any testing sessions\n  * Willing to refrain from any exercise and additional moderate to strenuous physical activity 24 hours prior to testing\n  * Willing to stay and exercise in an altitude chamber (the size of a dorm room) for \\~6 hours\n  * Supervisor approval for federal civilian employees and non-HRV active-duty military personnel stationed at NSSC.\n\nExclusion Criteria:\n\n* • Females who are pregnant, planning to become pregnant during the study, or breastfeeding.\n\n  * Taking prescription, over the counter medication, or dietary supplements, other than a contraceptive (unless approved by OMSO and Principal Investigator (PI))\n  * Tobacco or nicotine users, or anyone who has used tobacco or nicotine within the last four months\n  * Physical problems\u002Finjuries (e.g., current stress fractures, musculoskeletal strains) that would affect walking or running on a treadmill\n  * Allergy to skin adhesive\n  * Heart, lung, kidney, muscle, endocrine, or nerve disorder(s) as determined by OMSO\n  * History of heat intolerance or orthostatic intolerance\n  * Diagnosed and\u002For treated for fluid\u002Felectrolyte imbalance within the last 30 days\n  * History of obstructive disease of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis.\n  * Scheduled MRI within 2 weeks after completing a heat or cold test\n  * Actively dieting with the intent to lose weight\n  * History of cold injuries of any severity (e.g., frostbite, trench foot, chilblains).\n  * Raynaud's syndrome\n  * Cold-induced asthma\u002Fbronchospasm\n  * Not willing to have small areas of skin on the body shaved (if deemed necessary for attachment of study instrumentation)\n  * Born at altitudes greater than 2,100 m (7,000 ft) (e.g., Mexico City, Mexico)\n  * Living in areas that are more than 1,200 m (4,000 ft) (e.g., Colorado Springs, CO) or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months\n  * Prior diagnosis of High Altitude Pulmonary Edema (HAPE) or High Altitude Cerebral Edema (HACE)\n  * Abnormal blood count in accordance with OMSO - Normal Hb women: 11.1-15.9 g·dL-1 or Normal Hct women: 34.0-48%, or presence of abnormal blood chemicals (hemoglobin S or Sickle Cell Trait)\n  * History of pneumothorax\n  * History of hypertension\n  * Blood donation within 8 weeks of beginning the study\n  * Any recent (within 4-6 weeks) and or expected history of prolonged periods of immobility or limited activity (including recent or upcoming surgery)\n  * Evidence of apnea or sleeping disorder (narcolepsy, insomnia, etc.)",{"count":470,"type":23},33,"Over recent years, military service women have shown increasing interest in utilizing long-acting reversible contraceptives (LARCs; i.e., implants or intrauterine devices, IUDs). While clinically, LARC have been proven safe and effective at preventing pregnancy \\& decreasing menstrual symptoms, it is unclear what impact this type of contraceptive may have on physiological responses to extreme environments (heat, cold and high altitude). Additionally, iron deficiency and iron deficiency anemia are prevalent in U.S. military women which likely affect health and performance. There is evidence to suggest that the prevalence of iron deficiency and iron deficiency anemia is lower in women utilizing LARCs, which preserve iron stores, likely due to reduced menstrual blood loss that compounds with each cycle over the course of months. Due to the increasing interest in the utilization of LARCs it is important to understand what, if any, impact these methods of contraception may have on a female Soldier's physiological responses.\n\nThe overall goal of the present study is to characterize iron status and physiological responses (including but not limited to sweating, skin blood flow, ventilation, and heart rate) to extreme environmental stressors of heat, cold and high altitude (i.e. hypobaric hypoxia) in women utilizing LARCs. Up to thirty-three individuals (n=18 LARCs, n=15 monophasic oral contraceptives) will complete testing visits separated by at least 48 hours for environmental testing visits. During heat stress testing, measures of core body temperature, skin temperature, and sweat rate will be measured during a standardized protocol in hot, humid conditions. During cold stress, measures of body core temperature, metabolic heat production, skin blood flow and temperature (at both distal extremity and proximal body sites) will be assessed in order to better quantify the impact of exogenous sex hormones via LARCs and OCs in volunteers exposed to the cold. Measurements will be obtained during a standardized protocol in cold air (\\~90 min; 10°C). For altitude, cardiopulmonary responses will be assessed during rest and exercise during an acute altitude exposure (4300m). Blood samples will be collected throughout the investigation in order to quantify sex hormone concentrations, iron status, and inflammatory biomarkers in response to environmental stressors. The investigators will also utilize laboratory tests (i.e., carbon monoxide (CO) rebreathing technique) and collect blood samples to quantity iron stores in these groups of women. To characterize iron status, the Soldier Performance Health and Readiness (SPHERE) epidemiological data repository will be utilized to quantify the prevalence of iron deficiency and iron deficient anemia diagnoses between women using LARCs and women not utilizing LARCs.",[29,473],"Iron Deficiencies","2026-04-29",{"date":476,"type":34},"2026-04-30",{"date":478,"type":34},"2024-11-01",{"date":459,"type":23},{"name":481,"class":482},"United States Army Research Institute of Environmental Medicine","FED",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":105,"enrollmentInfo":490,"targetDuration":4,"studyType":24,"phases":492,"briefSummary":493,"conditions":494,"keywords":495,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":4},"100634213","phase-3-arterial-vascular-effects-of-estetrol-drospirenone-combined-oral-contraceptive-pill-100634213","NCT07536763","Arterial Vascular Effects of Estetrol-drospirenone Combined Oral Contraceptive Pill","Effect of Estetrol-drospirenone Combined Oral Contraceptive Pill on Arterial Vascular Risks","Inclusion Criteria:\n\n* Aged between 18 and 49 years inclusive\n* Considering to use the COC pill for contraception or treatment of menstrual disorders\n\nExclusion Criteria:\n\n* Being diagnosed with menopause\n* Having contraindications to COC, including (but not confined to) hypertension, diabetes mellitus with complications, history of ischaemic heart disease, thromboembolism, stroke, severe liver disease, oestrogen-sensitive cancers, undiagnosed abnormal uterine bleeding, smokers aged 35 years or above, or having body mass index \\>=35 kg\u002Fm2\n* Planning to get pregnant in the coming 1 year\n* Having been pregnant in the past 3 months\n* Having been on COC or hormone replacement therapy in the past 3 months (those who had been on these agents can stop these for 3 months as wash-out period before being recruited; this concurs with other similar studies in the literature)\n* Having been on anti-hypertensive, anti-diabetic or lipid-lowering agents in the past 3 months\n* Refusal to randomization",{"count":491,"type":23},98,[184],"The goals of this clinical trial are to investigate the effect of the estetrol (E4)-drospirenone combined oral contraceptive (COC) pill on flow-mediated dilatation (FMD) of the brachial artery and pulse wave velocity (PWV), in comparison to the ethinylestradiol (EE)-levonorgestrel COC pill, and to compare their respective effects on blood pressure, chronic inflammatory markers, as well as glycaemic and lipid indices.\n\nThe main questions it aims to answer are:\n\nDoes E4-drospirenone COC have significantly smaller effects then EE-levonorgestrel COC on FMD, PWV, blood pressure, chronic inflammatory markers, as well as glycemic and lipid indices.\n\nResearchers will compare E4-drospirenone to EE-levonorgestrel to see if the former has lower arterial vascular and metabolic risks.\n\nParticipants will:\n\n* be randomised to take E4-drospirenone or EE-levonorgestrel COC pill according to product insert;\n* visit the clinic at baseline and 6 and 12 months post-recruitment for checkups and tests",[29],[496,497,498,499,500],"Estetrol-drospirenone","Ethinylestradiol-levonorgestrel","Combined oral contraceptives","Arterial risks","Metabolic risks","2026-04-24",{"date":503,"type":34},"2026-04-27",{"date":505,"type":23},"2026-07",{"date":507,"type":23},"2029-06",{"name":509,"class":41},"Dr. Hang Wun Raymond Li",{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":516,"maxAge":257,"enrollmentInfo":517,"targetDuration":4,"studyType":24,"phases":519,"briefSummary":520,"conditions":521,"keywords":522,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":525,"lastUpdatePostDateStruct":526,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":303},"100473414","phase-4-levonorgestrel-52-mg-iud-for-emergency-contraception-and-same-day-start-100473414","NCT05444582","Levonorgestrel 52 mg IUD for Emergency Contraception and Same-Day Start","Inclusion Criteria:\n\n* Meet clinic eligibility for IUD placement\n* Have a LNG 52 mg IUD placed for either emergency contraception (had unprotected intercourse in the last 5 days) OR Same-day start, \\>7 days since the onset of last menstrual period and have no report of unprotected intercourse in the last 5 days\n* Negative high sensitivity urine pregnancy test prior to IUD placement.\n* No known contraindications to the LNG 52 mg IUD per the CDC Medical Eligibility Criteria for Contraceptive Use 2016\n* Have had penile-vaginal intercourse at least once since their last menstrual period. If last menstrual period is unknown or irregular, then have had penile-vaginal intercourse at least once in the last month.\n* Fluent in English or Spanish\n* Working Cell Phone number that receives text messages\n* Willing to comply with the study requirements including providing 1-month follow up data including a urine pregnancy test result one month after IUD placement\n\nExclusion Criteria:\n\n* Current pregnancy\n* Currently Breastfeeding\n* Current use of permanent contraception (has had a hysterectomy, tubal permanent contraception, or partner with a vasectomy in the last month)\n* Use of any contraceptive pills, patches, vaginal rings or any contraceptive implant or IUD use in the last 4 weeks\n* Use of oral emergency contraception in last 5 days\n* Vaginal bleeding of unknown etiology\n* Use of injectable hormonal contraceptive (Depo-Provera) in the last 6 months\n* Planned use of any non-contraceptive estrogen, progesterone, or testosterone\n* Acute cervicitis\n* Known abnormalities of the uterus that distort the uterine cavity\n* Ended pregnancy at or under 20 weeks gestational age within the last 2 weeks\n* Ended pregnancy over 20 weeks gestational age within the last 6 weeks","16 Years",{"count":518,"type":23},1404,[26],"This is a prospective clinical research study to test the effectiveness of the Levonorgestrel (LNG) 52 mg Intrauterine Device (IUD) for emergency contraception (EC) and same-day start use that will enroll people receiving care at Planned Parenthood affiliates across the U.S. Our prior work demonstrated efficacy (shows that it works in an ideal setting) for the LNG 52 mg IUD for these uses and this study will test effectiveness (how well it works in the real world) in a larger, heterogenous population in a usual care setting where participants select their method and are not randomly assigned to it. The study population will include people initiating an LNG 52 mg IUD and meet inclusion and exclusion criteria at 8 Planned Parenthood affiliates nationwide. Planned Parenthood Federation of America was the first major healthcare organization to change its practice to incorporate the changes we are studying here. As such, all study participants will be offered the opportunity to choose the interventional IUD at the site they visit. The primary outcome is pregnancy status one month after LNG IUD placement by home urine pregnancy test or clinical record review. Participant follow up concludes one month after enrollment.\n\nThe purpose of this study is to demonstrate reproducibility of earlier findings in a more heterogenous population. As such, IUD placement is not a study procedure but a component of clinical care. The study interventions only involve study participation and provision of data around the use of the levonorgestrel 52 mg IUD for EC or same day start.",[29],[523,524],"Emergency Contraception","IUD","2026-04-13",{"date":527,"type":34},"2026-04-16",{"date":529,"type":34},"2022-11-07",{"date":531,"type":23},"2027-07-31",{"name":533,"class":41},"University of Utah",{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":17,"sex":18,"minAge":51,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":24,"phases":543,"briefSummary":544,"conditions":545,"keywords":546,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":42},"100442713","kuwa-free---live-free-100442713","NCT05044962","Kuwa Free! - Live Free!","Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives","Inclusion Criteria (PK study):\n\n* Female sex,\n* HIV-positive (for PK groups #1-4) or HIV-uninfected (for PK group #5 only),\n* Age 15-24 years at the time of enrollment,\n* Documented or confirmed viral suppression for HIV (defined as \\\u003C40 copies\u002FmL) within 6 months prior to study enrollment,\n* Have been on the study oral drug for at least 4 weeks for the PK groups #1-4,\n* Have initiated and intends to use DMPA or implant for at least another three or 6 months, respectively,\n* Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period\n* Able to consent or assent (with parental consent) for study participation in English or Kiswahili\n\nExclusion Criteria (PK study):\n\n* Already be on ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir\u002Fritonavir or lopinavir\u002Fritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir\n* Currently pregnant or intends to become pregnant or breastfeeding within the next 12 or 24 weeks for DMPA or implant groups, respectively,\n* Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,\n* Use or anticipated use of drugs for the duration of the study period known to interact with hormonal implants or the study ART regimen,\n* Current or planned concomitant use of other hormonal contraceptives,\n* Be obese (BMI≥30),\n* Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: positive for HBsAg being excluded or negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded (of note, participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and\u002For current evidence) are immune to HBV and are not excluded).\n* Serum ALT\\>5x ULN at the time of screening,\n* Serum creatinine \\>2.5x ULN at the time of screening.\n\nInclusion Criteria Aim 1b (qualitative PK study):\n\n* Participating in PK study for study participants,\n* Self-identifying as provider, program person, policy-maker, or stakeholder relevant to the study topics, and age 18 years of age or older,\n* Able to consent for study participation in English or Kiswahili\n\nInclusion Criteria (Hybrid trial):\n\n* Female sex,\n* HIV-positive,\n* Age 15-24 years at the time of enrollment,\n* Documented or confirmed viral suppression for HIV (defined as \\\u003C40 copies\u002FmL) within 6 months prior to study enrollment,\n* Willing to undergo phlebotomy every 4-12 weeks for the duration of the study period,\n* Able to consent or assent (with parental consent) for study participation in English or Kiswahili\n\nExclusion Criteria (Hybrid trial):\n\n* Already be on ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir\u002Fritonavir or lopinavir\u002Fritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir\n* Currently pregnant or intends to become pregnant or breastfeeding within the next one year,\n* Have had unprotected sex in the last two weeks or be currently pregnant via urine pregnancy testing,\n* Use or anticipated use of drugs for the duration of the study period known to interact with the study ART regimen,\n* Evidence of Hepatitis B virus (HBV) infection based on the results of testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV Deoxyribonucleic acid (DNA) as follows: positive for HBsAg being excluded or negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded (of note, participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and\u002For current evidence) are immune to HBV and are not excluded).\n* Serum ALT\\>5x ULN at the time of screening,\n* Serum creatinine \\>2.5x ULN at the time of screening.\n\nInclusion Criteria Aim 2b (qualitative study):\n\n* Participating in hybrid trial study for study participants,\n* Self-identifying as provider, program person, policy-maker, or stakeholder relevant to the study topics, and age 18 years of age or older,\n* Able to consent for study participation in English or Kiswahili","24 Years",{"count":236,"type":23},[56],"The study investigators are conducting foundational pharmacokinetic (PK) and qualitative studies, among 15-24 years old (inclusive) adolescent girls and young women living with HIV (AGYWLHIV) already on oral antiretroviral therapy (ART) and virally suppressed, leading up to a hybrid type I effectiveness-implementation trial randomizing individual AGYWLHIV to receive long-acting (LA) injectable cabotegravir\u002Frilpivirine vs. standard of care within one of Kenya's largest HIV treatment programs. The PK and qualitative studies will investigate potential issues arising from co-delivery and guide delivery of the effectiveness-implementation trial. The PK and qualitative studies will largely be conducted with a sentinel cohort of AGYWLHIV. Learning from this early LA ART use, the investigators will refine the procedures in the LA ART hybrid trial.",[209,29,210],[547,214,283,548,215,549],"Kenya","Long-acting antiretroviral therapy","Injectable rilpivirine","2026-04-08",{"date":525,"type":34},{"date":553,"type":34},"2021-11-26",{"date":555,"type":23},"2027-03-31",{"name":227,"class":41},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":76,"enrollmentInfo":564,"targetDuration":4,"studyType":24,"phases":566,"briefSummary":567,"conditions":568,"keywords":569,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":576,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":581,"locationsCount":42},"100542647","drospirenone-only-pills-and-cervical-mucus-changes-a-pre--and-post-bariatric-surgery-study-100542647","NCT06345586","Drospirenone Only Pills and Cervical Mucus Changes: A Pre- and Post-Bariatric Surgery Study","Drospirenone Only Pills and Cervical Mucus Changes in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study","Inclusion Criteria:\n\n* Thai women aged 18-45 years who are obese and had an appointment for Bariatric surgery at Chulalongkorn Hospital\n* Need contraception\n* Able to use non-hormonal contraception during the study\n* Giving consent\n\nExclusion Criteria:\n\n* Pregnancy or history of giving birth within 3 months\n* Breastfeeding within the 6 months\n* History of using DMPA within 12 months\n* History of using other types of hormonal birth control pills within 4 weeks\n* History of bilateral oophorectomy or hysterectomy\n* Suspected ovarian tumor or pathological ovarian cyst\n* Regular cigarette smoking\n* Contraindications to Drospirenone",{"count":565,"type":23},16,[56],"The purpose of this study is to study the effect of Drospirenone on cervical mucus change by modified Insler score, pre-bariatric surgery and post-bariatric surgery",[29],[570,571,572,573,574],"Drospirenone only pills","Obesity","Bariatric surgery","Roux-en-Y gastric bypass","Cervical mucus","2026-03-17",{"date":577,"type":34},"2026-03-18",{"date":579,"type":34},"2024-04-18",{"date":505,"type":23},{"name":582,"class":41},"Chulalongkorn University",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":76,"enrollmentInfo":589,"targetDuration":4,"studyType":24,"phases":590,"briefSummary":592,"conditions":593,"keywords":594,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":575,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":600,"leadSponsor":601,"locationsCount":42},"100542645","phase-1-pharmacokinetics-of-drospirenone-only-pills-a-pre--and-post-bariatric-surgery-study-100542645","NCT06345560","Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study","Pharmacokinetics of Drospirenone Only Pills in Obese Thai Women: A Pre- and Post-Bariatric Surgery Study",{"count":565,"type":23},[591,80],"PHASE1","The purpose of this study is to investigate whether bariatric surgery affects Drospirenone only pills absorption",[29],[570,571,572,573,595,596],"Pharmacokinetics","Absorption",{"date":598,"type":34},"2026-03-19",{"date":579,"type":34},{"date":505,"type":23},{"name":582,"class":41},{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":17,"sex":18,"minAge":135,"maxAge":301,"enrollmentInfo":610,"targetDuration":4,"studyType":24,"phases":612,"briefSummary":613,"conditions":614,"keywords":615,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":303},"100514381","prospective-multi-center-trial-for-fembloc-permanent-birth-control-100514381","NCT05977751","Prospective Multi-Center Trial for FemBloc Permanent Birth Control","FINALE: Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control","FINALE","Inclusion Criteria:\n\n* Female, 21 - 50 years of age desiring permanent birth control.\n* Sexually active with male partner.\n* Regular menstrual cycle for last 3 months or on hormonal contraceptives.\n\nExclusion Criteria:\n\n* Uncertainty about the desire to end fertility.\n* Known or suspected pregnancy.\n* Prior tubal surgery, including sterilization attempt.\n* Presence, suspicion, or previous history of gynecologic malignancy.\n* Scheduled to undergo concomitant intrauterine procedures (i.e. endometrial ablation) at the time of either FemBloc Treatment or prior to final confirmation test.\n* Abnormal uterine bleeding requiring evaluation or treatment.",{"count":611,"type":23},573,[56],"Prospective, multi-center, international, unblinded, single-arm trial of subjects undergoing FemBloc followed by ultrasound confirmation test.",[29],[616,617,618],"Permanent Birth Control","Permanent Contraception","Permanent Sterilization","2026-03-01",{"date":621,"type":34},"2026-03-03",{"date":623,"type":34},"2023-10-31",{"date":625,"type":23},"2031-06",{"name":627,"class":195},"Femasys Inc.",{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":632,"acronym":633,"eligibilityCriteria":634,"healthyVolunteers":12,"sex":18,"minAge":516,"maxAge":257,"enrollmentInfo":635,"targetDuration":4,"studyType":24,"phases":637,"briefSummary":638,"conditions":639,"keywords":641,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":643,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":4},"100627489","phase-3-rct-assessing-pregnancy---piroxicam-for-ec-with-levonorgestrel-100627489","NCT07449299","Rct Assessing Pregnancy - Piroxicam for Ec With Levonorgestrel","RAPPEL","Inclusion Criteria:\n\n* Between 16-35 years old and desire LNG for EC\n* Unprotected intercourse within 72 hours\n* Biologically capable of pregnancy\n* Regular menstrual cycle 21-35 days long with known LMP +\u002F- 3 days\n* Working cell phone number that receives text messages (for Aim 3 participants phone with capability to download and use the Oova application and submit data)\n* Fluent in English and\u002For Spanish\n* Willing to comply with the study requirements including 1-month urine pregnancy test\n* No known contraindications to oral LNG or piroxicam - For secondary outcome assessing pregnancy risk for participants receiving study drug on day of ovulation or later - are currently using a menstrual cycle tracking application and can demonstrate according to the application that they are on the day of ovulation or post ovulation.\n\nExclusion Criteria:\n\n* Current pregnancy (+urine pregnancy test in clinic)\n\n  * Breastfeeding, post abortion or postpartum without resuming menstruation\n  * Use of hormonal contraception (including oral EC) within seven days of enrollment\n  * Use of NSAIDs (ibuprofen, naproxen, celecoxib, diclofenac, aspirin) in the prior week\n  * Highly effective contraception including permanent contraception (including partner with vasectomy), IUD, or contraceptive implant\n  * Allergy to LNG or piroxicam\n  * Desires UPA for EC\n\nHistory of stroke, myocardia infarction, ischemic heart disease, uncontrolled hypertension, congestive heart failure, peptic ulcer disease, renal or hepatic failure. Currently taking anticoagulants, corticosteroids, cyclosporine, lithium, methotrexate, or tacrolimus.",{"count":636,"type":23},1458,[184],"This randomized controlled trial will test oral levonorgestrel + piroxicam vs. levonorgestrel + placebo for emergency contraception in a representative U.S. population that has higher pregnancy risk than in the prior study because of higher weights, different intercourse patterns, and different clinic accessibility. Data from this project will inform clinical practice in the U.S. and beyond for those desiring the most effective method of emergency contraception pills.",[523,29,640],"COX-2 Inhibitor",[523,642,29],"Piroxicam","2026-02-26",{"date":645,"type":34},"2026-03-04",{"date":647,"type":23},"2027-03",{"date":649,"type":23},"2031-11",{"name":533,"class":41}]