[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulvovaginal-candidiasis-vvc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulvovaginal-candidiasis-vvc":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,54,76,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100645964","photobiomodulation-for-vaginal-dysfunctions-home-based-vs-outpatient-treatment-100645964",false,"NCT07697768","Photobiomodulation for Vaginal Dysfunctions: Home-Based vs Outpatient Treatment","Therapeutic Response to Photobiomodulation in Home-Based and Outpatient Protocols for Vaginal Dysfunctions: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Women aged 18 to 75 years.\n* Clinical and\u002For laboratory-confirmed diagnosis of Genitourinary Syndrome of - Menopause (GSM), Bacterial Vaginosis (BV), or Vulvovaginal Candidiasis (VVC), according to established diagnostic criteria.\n* Ability to understand study procedures and provide written informed consent.\n* Willingness to comply with study procedures and follow-up assessments.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Use of a pacemaker or other implanted electronic medical device.\n* Active gynecological malignancy or suspicion of gynecological cancer.\n* Neurological and\u002For psychiatric disorders associated with cognitive impairment that may interfere with understanding study procedures.\n* Use of antibiotics, antifungal agents, corticosteroids, or vaginal creams within the previous 30 days in participants diagnosed with BV and\u002For VVC.\n* Suspected or confirmed vulvovaginal conditions other than GSM, BV, or VVC.\n* Any condition deemed by the investigators to compromise participant safety or interfere with study participation.","FEMALE","18 Years","75 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","Vaginal disorders, including vulvovaginal candidiasis (VVC), bacterial vaginosis (BV), and genitourinary syndrome of menopause (GSM), are highly prevalent conditions that significantly affect women's quality of life and sexual health. These disorders are associated with inflammatory changes, vaginal dysbiosis, and symptoms such as pruritus, abnormal vaginal discharge, dryness, and dyspareunia. In this context, photobiomodulation has emerged as a noninvasive therapeutic approach with anti-inflammatory and tissue-repair properties. This study is a randomized clinical trial designed to compare the therapeutic response to blue LED photobiomodulation (401 ± 5 nm) delivered through home-based and outpatient treatment protocols. A total of 150 women aged 18 to 75 years with a diagnosis of GSM, BV, or VVC will be enrolled and randomly assigned to one of two treatment groups. Clinical and laboratory assessments will be performed before and after treatment. Participants will also complete the Female Sexual Function Index (FSFI) and the 36-Item Short Form Health Survey (SF-36). Outcomes will include the evaluation of gynecological signs and symptoms, sexual function, quality of life, treatment adherence, and adverse events. The anticipated risks are minimal and primarily related to potential discomfort during gynecological examinations and possible embarrassment associated with discussing sensitive health information. The study is expected to demonstrate that photobiomodulation may improve clinical and functional outcomes, representing a safe, non-hormonal therapeutic alternative for the management of vaginal disorders.",[27,28,29],"Genitourinary Syndrome of Menopause (GSM)","Bacterial Vaginosis","Vulvovaginal Candidiasis (VVC)",[31,32,33,34,28,35,36,37,38,39,40],"Photobiomodulation","Blue LED","Vaginal Disorders","Vulvovaginal Candidiasis","Genitourinary Syndrome of Menopause","Sexual Function","Non-Hormonal Therapy","Randomized Clinical Trial","Home-Based Therapy","Outpatient Therapy","NOT_YET_RECRUITING","2026-07-09",{"date":44,"type":45},"2026-07-13","ACTUAL",{"date":47,"type":21},"2026-07-30",{"date":49,"type":21},"2028-05-20",{"name":51,"class":52},"Patricia Lordelo","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":53},"100640908","evaluation-of-the-efficacy-of-a-probiotic-product-as-an-adjuvant-treatment-for-vulvovaginal-candidiasis-100640908","NCT07603895","Evaluation of the Efficacy of a Probiotic Product as an Adjuvant Treatment for Vulvovaginal Candidiasis","Inclusion Criteria:\n\n* Women of reproductive age who use effective contraceptive methods during the course of the study.\n* Clinical suspicion of vulvovaginal candidiasis, in the investigator's judgment, based on the presence of symptoms - e.g., pruritus, burning sensation, irritation, dyspareunia and\u002For abnormal vaginal discharge - and\u002For compatible clinical findings.\n* Possibility of collecting a vaginal sample at the baseline visit for microbiological analysis.\n* Ability and willingness to comply with the study procedures and to sign the informed consent form\n\nExclusion Criteria:\n\n* Menstruation at the time of inclusion.\n* Pregnancy or breastfeeding.\n* Menopause or perimenopause.\n* Diabetes mellitus.\n* Presence of immunocompromised status or treatment with immunosuppressants within the 3 months prior to inclusion in the trial.\n* Vaginal coinfection in addition to vulvovaginal candidiasis.\n* Severe chronic diseases or other active infections that may interfere with the clinical assessment of vulvovaginal candidiasis, in the investigator's judgment.\n* History of intolerance or hypersensitivity to the intervention products.\n* Treatment with antifungals or probiotic supplements in the month prior to inclusion in the trial.",{"count":61,"type":21},60,[24],"Open-label, randomized clinical trial with a control group and a 4-week intervention period. The study will evaluate the efficacy of the probiotic supplement Bioithas WOMAN® as an adjunctive treatment in women with clinically suspected vulvovaginal candidiasis (VVC).\n\nAll participants will receive the antifungal treatment prescribed by the investigator. Participants allocated to the probiotic group will additionally receive Bioithas WOMAN®, supplied as a bottle containing 30 capsules, to be taken during the 4-week intervention period.\n\nThe study includes two on-site visits: Visit 1 (baseline) and Visit 2 (week 4\u002Fend of study). At baseline, demographic data, relevant gynecological history, VVC risk factors, clinical characteristics of the current episode, concomitant diseases, and usual pharmacological treatments will be recorded. Clinical symptoms associated with VVC, including abnormal vaginal discharge, pruritus, burning sensation, irritation, and dyspareunia, will be assessed, together with the Vaginitis Symptom Score (VSS).\n\nAt both visits, vaginal pH will be measured using an indicator strip applied to the vaginal mucosa. A vaginal sample will also be collected using a sterile swab for microbiological culture of Candida and semiquantitative assessment of Lactobacillus. Although randomization will be performed in women with clinical suspicion of VVC, microbiological confirmation by culture will be obtained after inclusion.\n\nAt the final visit, the same clinical and microbiological variables will be reassessed. Concomitant treatments, relevant follow-up observations, and any adverse events reported during the study will also be recorded. In the probiotic group, adherence to treatment will be assessed by counting the remaining capsules.",[29],"RECRUITING","2026-05-18",{"date":68,"type":45},"2026-05-22",{"date":70,"type":21},"2026-05-25",{"date":72,"type":21},"2026-12-31",{"name":74,"class":75},"Bioithas SL","INDUSTRY",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100591639","clinical-study-of-a-vaginal-cooling-device-for-the-treatment-of-vulvovaginal-candidiasis-vvc-100591639","NCT06983041","Clinical Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)","Open-label, Uncontrolled Clinical Research Study of a Vaginal Cooling Device for the Treatment of Vulvovaginal Candidiasis (VVC)","Inclusion Criteria:\n\n* Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the inclusion criteria.\n\n  1. Women between 22-49 years of age and not more than one year since last menses, with the suspected diagnosis of uncomplicated VVC.\n  2. Able to read and understand English.\n  3. Able to provide written informed consent and to understand and agree to all study procedures required.\n  4. Has a smart phone and has the ability to access and use the ValidCare app.\n  5. Documented Papanicolaou (Pap) test at baseline or during the previous 12 months reported as either \"negative for intraepithelial lesion or malignancy\" or \"ASCUS-atypical squamous cells of undetermined significance\" and negative for high-risk HPV types or negative colposcopy plus\u002Fminus biopsies were performed for high-risk HPV types.\n  6. Clinical diagnosis of symptomatic VVC confirmed by positive KOH wet mount and yeast culture at baseline.\n  7. Presence of at least one vulvovaginal sign (vulvovaginal erythema, edema, or excoriation) of VVC.\n  8. Presence of at least one vulvovaginal symptom (itching, pain or burning, irritation)\n  9. Willing and able to avoid vaginal (or any) sexual activity during the study period.\n  10. Menstrual products such as tampons, pads, and menstrual cups may be used during the study period including before and after device use.\n\nExclusion Criteria:\n\n* 1\\. Site investigators will evaluate the eligibility of women presenting with symptoms consistent with VVC based on the exclusion criteria.\n\n  2\\. Subject does not have a smart phone. 3. Subject does not have the ability to access and use the Validcare app. 4. Subjects who were treated for VVC within the past 14 days. 5. Use of systemic, topical (applied to the vulva) or vaginal antibiotics, anti-fungal or anti-trichomonas drugs within 14 days.\n\n  6\\. Use of any systemic corticosteroid, immunosuppressive, or immune-stimulating drug within 3 months.\n\n  7\\. History of douching within the previous 7 days. 8. Urinary tract infection. 9. Unable or unwillingness to use tampons in the past. 10. Unable to maintain study protocol including but not limited to the avoidance of sexual activity during the 28 days or time interval up to the assessment of the primary endpoint. This is needed to avoid reinfection, worsening of symptoms or new pathogen infection, while assessing the efficacy of the subject device in treating the primary infection.\n\n  11\\. Use of anticoagulation therapy (e.g., warfarin, heparin). 12. Diabetes mellitus. 13. History of vulvodynia, vestibulitis, vaginismus, radiation-induced vaginitis, or postmenopausal atrophy.\n\n  14\\. Immune compromised states such as HIV\u002FAIDS or transplant subjects. 15. Subjects with other infectious causes of vulvovaginitis or with mixed infections diagnosed at baseline. (Note: if any trichomonad trophozoites are seen on wet smear on the initial visit, the subject is to be excluded from the study.) 16. Symptomatic vulvar or vaginal condyloma or presence of another vaginal or vulvar condition that would confound the interpretation of clinical response.\n\n  17\\. Pregnancy. 18. Presence of trichomonad trophozoites on wet smear at the initial visit. 19. Any condition which, in the opinion of the investigator, should preclude participation in the study. If so, the investigator will collect information on the subjects who are determined to have a condition that precludes participation in the study and the reasons for their exclusion documented within the DDCS to ensure there is no bias introduced.","22 Years","49 Years",{"count":86,"type":21},55,[24],"The objective of this study is to determine clinical cure rate and safety of a proprietary Vaginal Cooling Device (VCD) in women with VCC. In addition, the safety, mycological cure rates, the speed and efficacy of symptom resolution, vaginal hyphae and polymorphonuclear (PMN) scores, and Quality-of-Life (QoL) parameters will be determined.",[29,90],"Yeast Vaginitis",[92],"yeast infection","2026-01-28",{"date":95,"type":45},"2026-01-30",{"date":97,"type":45},"2025-05-22",{"date":99,"type":21},"2026-06-30",{"name":101,"class":75},"Coologics, Inc",10,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100580289","phase-2-efficacy-and-safety-of-clotrimazolelactulose-vaginal-suppositories-vs-clotrimazole-monotherapy-in-adult-women-with-candidal-vaginitisvulvovaginitis-100580289","NCT06835361","Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis\u002FVulvovaginitis","International Open-label Randomized Comparative Clinical Study of Efficacy and Safety of Clotrimazole+Lactulose, Vaginal Suppositories (AVVA RUS JSC, Russia) Vs. a Clotrimazole Monocomponent Product in Adult Female Patients with Candidal Vaginitis\u002Fvulvovaginitis","Inclusion Criteria:\n\n* Women aged 18 to 60 years.\n* Clinically and microbiologically confirmed diagnosis of candidal vulvovaginitis.\n* Negative pregnancy test at screening.\n* Agreement to use reliable contraception throughout the study and for 30 days after its completion.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Diagnosed bacterial vaginosis.\n* Chronic inflammatory or atrophic diseases of the female genital organs.\n* History of malignant neoplasms.\n* Use of systemic antibiotics or antifungal drugs within 2 weeks prior to screening.","60 Years",{"count":112,"type":21},264,[114,115],"PHASE2","PHASE3","This study aims to compare the efficacy and safety of the combination drug Clotrimazole+Lactulose with the monocomponent product Canesten® (clotrimazole) in adult women diagnosed with candidal vulvovaginitis. The primary objective was to confirm the superiority of the combination drug in terms of clinical and microbiological response on Day 25 of the study.",[118,29],"Candidal Vulvovaginitis (ICD-10 Code: B37.3)",[120,121,34,122,123,124,125,126,127,128,129,130],"Clotrimazole+Lactulose","Candidal Vulvovaginitis","Clotrimazole","Lactulose","Antifungal Therapy","Prebiotic","Vaginal Suppositories","Canesten","Microbiological Recovery","Women's Health","Vaginal Microbiota","2025-02-14",{"date":133,"type":45},"2025-02-19",{"date":135,"type":45},"2024-02-29",{"date":137,"type":21},"2025-11-30",{"name":139,"class":75},"AVVA Pharmaceuticals Ltd.",7]