[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"menopausal-hormone-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:menopausal-hormone-therapy":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,89],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100649486","phase-4-hormone-therapy-effects-on-brain-heart-health-during-the-menopausal-transition-100649486",false,"NCT07732452","Hormone thERapy Effects on BRAin-HEART Health During the Menopausal Transition","HER BRAVE HEART Trial - Hormone thERapy Effects on BRAin-HEART Health During the Menopausal Transition: A Randomized Feasibility Study","HERBRAVEHEART","Inclusion Criteria:\n\n* Women aged ≥ 45 years.\n* Perimenopausal or postmenopausal, defined as at least one of the following:\n\n  * Perimenopause, defined as menstrual cycle irregularity (changes in cycle length, skipped cycles, or amenorrhea ≥ 60 days) accompanied by vasomotor symptoms consistent with the menopausal transition.\n  * Postmenopause, defined as at least one of:\n\n    * ≥ 12 months of spontaneous amenorrhea, or\n    * bilateral oophorectomy, or\n    * hysterectomy with FSH \\> 40 IU\u002FL when menstrual history is unavailable.\n* Vasomotor symptoms with a negative impact on quality of life, defined as :\n\n  * Recurrent hot flashes (sudden sensations of heat, typically involving the face, neck, or chest, often associated with flushing and\u002For sweating), and\u002For\n  * Night sweats (episodes of excessive sweating during sleep), With associated interference in daily functioning, sleep, or overall quality of life, such that the participant would be an appropriate candidate for systemic menopausal hormone therapy in clinical practice.\n* Presence of at least one cardiovascular risk factor, defined as either:\n\n  * Hypertension (diagnosed hypertension, use of antihypertensive medication, or blood pressure ≥ 140\u002F90 mmHg on screening).\n  * Dyslipidemia (diagnosed dyslipidemia, use of lipid-lowering therapy, LDL ≥ 3.0 mmol\u002FL, or total cholesterol ≥ 5.2 mmol\u002FL).\n  * Type 2 diabetes mellitus, defined as HbA1c ≥ 6.5%, fasting plasma glucose ≥ 7.0 mmol\u002FL, or use of glucose-lowering medication.\n  * Obesity (body mass index ≥ 30 kg\u002Fm²).\n  * Current smoking.\n  * First-degree family history of premature cardiovascular disease, defined as myocardial infarction, stroke, or documented coronary artery disease occurring before age 55 years in a male relative or before age 65 years in a female relative.\n* Eligible for systemic MHT (i.e., no formal contraindication to MHT).\n* Able and willing to undergo research CMR and attend the 12-month follow-up assessment.\n* Able to provide written informed consent.\n* Not currently using systemic MHT at baseline, or willing to discontinue systemic MHT prior to randomization and remain off systemic MHT until allocation and baseline assessments are complete.\n\nExclusion Criteria:\n\n* Prior cardiovascular event or established cardiovascular disease, including myocardial infarction, stroke or TIA, coronary artery disease, heart failure, cardiomyopathy, or clinically significant valvular heart disease.\n* Uncontrolled hypertension or other unstable cardiovascular condition (e.g., unstable angina, decompensated heart failure, uncontrolled arrhythmia).\n* Formal contraindication to systemic menopausal hormone therapy, including estrogen-dependent cancer, unexplained vaginal bleeding, active severe liver disease, severe thrombophilia, antiphospholipid syndrome, prior or active VTE.\n* Standard contraindications to MRI (e.g., MRI-incompatible pacemakers or intracardiac devices, certain metallic implants, metallic foreign bodies in the eye, or severe claustrophobia not manageable).\n* Pregnant.\n* Active cancer on ongoing cardiotoxic chemotherapy.\n* Current use of systemic hormonal therapy outside the study strategy, including systemic menopausal hormone therapy, combined hormonal contraception, or systemic progestin-only contraception, with unwillingness or inability to discontinue prior to baseline and randomization.\n* Ten years or more since menopause, defined as ≥10 years from the final menstrual period or from bilateral oophorectomy\n* Participants currently using combined hormonal contraception or systemic progestin-only contraception who are willing to discontinue must complete a washout period of at least 4 weeks prior to the baseline visit and randomization","FEMALE","45 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this clinical trial is to learn whether it is feasible to conduct a larger study comparing transdermal menopausal hormone therapy (MHT) versus no hormone therapy in menopausal women with vasomotor symptoms (hot flashes and night sweats) and at least one cardiovascular risk factor. The main questions it aims to answer are:\n\n* What proportion of eligible women agree to be randomly assigned to either receive MHT or not?\n* How many participants complete the 12-month follow-up, including repeat heart imaging?\n* Does transdermal MHT affect early changes in heart muscle tissue as measured by cardiac MRI?\n\nResearchers will compare immediate initiation of transdermal estradiol (a skin gel or patch) to a no-hormone therapy strategy to see if MHT influences early cardiovascular and brain-vascular changes over 12 months.\n\nParticipants will:\n\n* Be randomly assigned to start transdermal MHT within 2 weeks, or to use no hormone therapy for at least the first 3 months\n* Undergo a cardiac MRI and retinal eye imaging at the start of the study and again at 12 months\n* Complete cognitive testing and questionnaires about symptoms, sleep, and stress at both visits\n* Provide a blood sample for storage and future analysis of heart and brain health markers\n* Receive follow-up phone calls at 3, 6, and 9 months to review symptoms, medications, and any health changes",[27,28,29,30,31,32,33,34,35],"Menopause","Perimenopause","Vasomotor Symptoms","Cardiovascular Disease Risk Factor","Menopausal Hormone Therapy","Cardiac Remodeling","Myocardial Fibrosis","Microvascular Dysfunction","Cognitive Function Assessment","NOT_YET_RECRUITING","2026-07-23",{"date":39,"type":40},"2026-07-29","ACTUAL",{"date":42,"type":21},"2026-11",{"date":44,"type":21},"2029-01",{"name":46,"class":47},"McGill University Health Centre\u002FResearch Institute of the McGill University Health Centre","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":58,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":70,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100638708","a-retrospective-and-prospective-clinical-registry-for-data-collection-of-perimenopausal-menopausal-and-premature-ovarian-insufficiency-women-100638708","NCT07606326","A Retrospective and Prospective Clinical Registry for Data Collection of Perimenopausal, Menopausal and Premature Ovarian Insufficiency Women","Inclusion Criteria:\n\n* 1\\. Age: women aged 18-60 years at the time of enrollment and in follow up, up to 65 years old\n* 2\\. Women in Perimenopause, defined as the transitional period preceding the final menstrual period, characterized by changes in menstrual cycle regularity and\u002For the onset of menopausal symptoms. Women experience variable cycle length, skipped cycles, or amenorrhea of less than 12 months' duration, often accompanied by vasomotor symptoms, sleep disturbances, and other menopause-related complaints.\n* 3\\. Women in Menopause, defined as the permanent cessation of menstruation resulting from loss of ovarian follicular activity and is diagnosed retrospectively after 12 consecutive months of amenorrhea in the absence of other pathological or physiological causes. Women may present with persistent menopausal symptoms and\u002For long-term consequences of estrogen deficiency, including changes in bone, cardiovascular, metabolic, and genitourinary health.\n\nlt includes women in early Menopause, defined as menopause occurring before the age of 45 years, but after 40 years, in the absence of surgical or iatrogenic causes.\n\n* 4\\. Women in Premature Ovarian lnsufficiency (POI), defined as impaired ovarian function occurring before the age of 40 years, characterized by oligo- or amenorrhea, elevated gonadotropin levels, and hypoestrogenism.\n* 5\\. Women with iatrogenic menopause, caused by:\n* Bilateral oophorectomy\n* Chemotherapy or radiotherapy-induced ovarian failure\n* Other pharmacological treatments resulting in ovarian insuftficiency\n* 6\\. Women evaluated at the specialized Menopause Clinic or the Multidisciplinary Endocrinology\u002FMetabolic Disorders clinic.\n* 7\\. Data availability: for retrospective participants, sufficient medical records must be available; tor prospective participants, patients must be willing to participate in the registry and provide informed consent.\n* 8\\. All women are eligible regardless of concomitant diseases, to reflect real-world clinical practice.\n\nExclusion Criteria:\n\n* 1\\. Women unable to provide informed consent due to cognitive impairment or severe psychiatric conditions.\n* 2\\. Women already participating in interventional clinical trials affecting menopausal or metabolic management in a way that could bias observational data.\n* 3\\. Women with incomplete medical records for retrospective data collection or those refusing informed consent for prospective enrollment.","18 Years","65 Years",{"count":57,"type":21},5000,"20 Years","OBSERVATIONAL","This study is designed as on observational, retrospective, and prospective clinical registry aimed at collecting comprehensive real-world data on women in perimenopause, menopause, and with premature ovarian insufficiency (POI) attending a specialized Menopause Clinic and a Multidisciplinary Outpatient Clinic dedicated to Endocrinology and Metabolic Disorders.\n\nThe registry comprises both retrospective data, extracted from the medical records of eligible patients evaluated from January 2000 onward, and prospective data, which will be continuously collected for all newly referred patients up to 2040. This combined design allows the longitudinal observation of clinical characteristics, management strategies, and health outcomes across different stages of the menopausal transition and premature ovarian insufficiency within routine clinical practice.\n\nClinical management and therapeutic strategies, including hormone replacement therapy and non-hormonal interventions, will be documented. Laboratory data, as well as imaging data routinely used in clinical practice, will be recorded when available.\n\nEnrolled patients will undergo a personalized follow-up schedule based on clinical findings and the conclusions of each visit, in accordance with standard clinical practice. Follow-up visits may be scheduled annually for routine monitoring or at shorter intervals (semi-annual or quarterly) in the presence of conditions requiring closer clinical surveillance.\n\nThe registry is intended to reflect real-world clinical practice and to support the descriptive evaluation of patterns of care, symptom burden, and longitudinal clinical outcomes in women undergoing the menopausal transition or affected by premature ovarian insufficiency. The collected data will provide a structured platform for epidemiological analyses and hypothesis-generating observational research aimed at improving the understanding and management of menopausal health and associated endocrine and metabolic conditions.",[27,31,62,63,64,65,66,67,68,69],"Menopause Surgical","Menopause Related Conditions","Menopausal Complaints","Menopausal Osteoporosis","Menopause-related Hot Flashes","Menopausal and Perimenopausal Disorder, Unspecified","Menopausal and Postmenopausal Women","Premature Ovarian Failure (POF)",[71,72,73,74,75,76,77,78,79],"menopause","perimenopause","premature ovarian failure","hormonal replacement teraphy","osteoporosis","genitourinary syndrome of menopause","hot flashes","menopausal discomfort","menopausal symptoms","2026-05-19",{"date":82,"type":40},"2026-05-26",{"date":84,"type":21},"2026-06",{"date":86,"type":21},"2040-12",{"name":88,"class":47},"IRCCS San Raffaele",{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":97,"enrollmentInfo":98,"targetDuration":4,"studyType":22,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100631101","comparison-of-oral-dydrogesterone-and-vaginal-progesterone-in-menopausal-hormone-therapy-100631101","NCT07496294","Comparison of Oral Dydrogesterone and Vaginal Progesterone in Menopausal Hormone Therapy","Comparison of Oral Dydrogesterone and Vaginal Micronized Progesterone Regimens Combined With Transdermal Estradiol in Menopausal Hormone Therapy: A Prospective Randomized Controlled Trial","PRO-MHT","Inclusion Criteria:\n\n* Women aged 45-60 years\n* Postmenopausal status (absence of menstruation for ≥12 months)\n* Intact uterus\n* Presence of menopausal symptoms requiring menopausal hormone therapy\n* Willingness to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Unexplained vaginal bleeding\n* History of breast cancer or endometrial cancer\n* Known hypersensitivity to study medications\n* History of thromboembolic disease (e.g., deep vein thrombosis or pulmonary embolism)\n* Severe liver disease\n* Uncontrolled hypertension\n* Any condition that, in the opinion of the investigator, makes participation inappropriate","60 Years",{"count":99,"type":21},200,[101],"NA","Menopause is a natural stage in a woman's life that can be associated with symptoms such as hot flashes, night sweats, sleep problems, and vaginal dryness. Menopausal hormone therapy is commonly used to relieve these symptoms. In women with an intact uterus, progesterone must be used together with estrogen to protect the lining of the uterus.\n\nThe purpose of this study is to compare two commonly used progesterone treatment methods in women receiving menopausal hormone therapy. All participants will use transdermal estradiol gel, and they will be randomly assigned to receive either oral dydrogesterone or vaginal micronized progesterone.\n\nThis prospective randomized controlled study will evaluate the effects of these treatments on endometrial thickness, menopausal symptoms, vaginal health parameters, bleeding patterns, and quality of life over a 12-month follow-up period.\n\nThe results of this study may help determine the most appropriate progesterone regimen for women undergoing menopausal hormone therapy.",[104,105,106,31],"Menopausal Women","Menopausal Symptom Relief","Hormone Therapy",[108,109,110,111,112,113,114,115],"Menopausal hormone therapy","Dydrogesterone","Micronized progesterone","Transdermal estradiol","Progesterone route of administration","Endometrial thickness","Postmenopausal women","Randomized controlled trial","2026-03-23",{"date":118,"type":40},"2026-03-27",{"date":120,"type":21},"2026-04",{"date":122,"type":21},"2027-10",{"name":124,"class":47},"Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital",1]