[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulvar-atrophy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulvar-atrophy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,54,86,112,140,170],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":38,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100590048","changes-in-the-impact-of-genitourinary-syndrome-of-menopause-with-a-novel-nonhormonal-vulvovaginal-gel-assessed-by-proms-100590048",false,"NCT06962345","Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs.","Changes in the Impact of Genitourinary Syndrome of Menopause With a Novel Nonhormonal Vulvovaginal Gel Assessed by PROMs. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial. Part of STOP GSM PROJECT.","STOPGSMP","Inclusion Criteria:\n\n* Patient has to have at least one symptom of GSM or suffer from symptoms related to vulvovaginal atrophy (as evidenced by gynecological examination with a Vaginal Health Index ≤15).\n* Patient must be postmenopausal with at least 1 year without a menstrual period.\n* Patient must consider that her quality of life is affected by GSM symptoms\n* Patient not followed due to any gynecological disease.\n* All participants must be able to understand and to fill in the self-reported questionnaires.\n\nExclusion Criteria:\n\n* Patients that do not want to fill the questionnaire, especially the questions that address sexual functioning.\n* Participants that use any oral products containing hormones or estrogen receptor modulators for the past 8 weeks, nor vaginal topical hormone products within 4 weeks, neither prescription nor non-prescription therapies for GSM, including topical vaginal non-hormonal lubricants or moisturizers for the last week.\n* Patients with history of vulvar, vaginal and\u002For cervical malignancy.\n* Patients having received radiotherapy treatment in the pelvic and\u002For genital region.\n* Patients with any type of disease that causes alteration of collagenogenesis.\n* Patients that use cytotoxic drugs leading to mucositis and alterations of tissue regeneration in the last 6 months.\n* Patients having received laser and\u002For radiofrequency treatment for handling genital atrophy or other pelvic floor dysfunctions.\n* Patients with active urinary and\u002For genital tract infection.\n* Patients with history of malignant neoplasm of the urinary system.\n* Patients with severe stress urinary incontinence (Sandvik test score equal to or greater than 8).\n* Patients with diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification.\n* Patients with medical or surgery history that, at the investigator's discretion, does not allow participation in the study.\n* Patients with any other condition that, at the investigator's discretion, implies that the patient is unable to understand the implication of participating in the study and\u002For following the established procedures.","FEMALE","40 Years","70 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to improve the management of Genitourinary syndrome of menopause (GSM) to preliminary assess safety and effectivity of a novel hormone-free mucosa composition (XCMIM20m) applied topically to the vulvovaginal area. Symptoms of vaginal atrophy will be compared before and after 8 weeks of use of the tested gel with the Day-to-Day Impact of Vaginal Aging (DIVA) PROMs questionnaire to assess changes impact of GSM symptoms.",[28,29,30,31,32,33,34,35,36,37],"Vulvar Atrophy","Vulvovaginal Signs and Symptoms","Genitourinary Syndrome of Menopause","Quality of Life","Menopause Related Conditions","Dyspareunia","Urinary Incontinence, Urgency-frequency","Sexual Function","Women´s Health","Vaginal Dryness",[30,29,39,31,40,36],"Patient Reported Outcome Measures","Day-to-Day Impact of Vaginal Ageing","RECRUITING","2026-03-25",{"date":44,"type":45},"2026-03-30","ACTUAL",{"date":47,"type":45},"2024-01-08",{"date":49,"type":22},"2026-12",{"name":51,"class":52},"Mucosa Innovations, S.L.","INDUSTRY",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100627591","efficacy-of-collagendep-in-reducing-vulvar-dryness-in-patients-with-lichen-sclerosus-treated-with-fat-grafting-100627591","NCT07450625","Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Lichen Sclerosus Treated With Fat Grafting","Study of the Efficacy of Collagendep in Reducing Vulvar Dryness in Patients With Genital Lichen Sclerosus Treated With Fat Grafting","Collagendep","Inclusion Criteria:\n\n* Female patients aged 18 years or older.\n* Clinical diagnosis of Genital Lichen Sclerosus.\n* Patients with a clinical indication for autologous fat grafting (lipofilling) treatment.\n* Ability to provide written informed consent.\n* Willingness to comply with the study protocol and attend all scheduled follow-up visits.\n\nExclusion Criteria:\n\n* Presence of active local or systemic infections.\n* Current pregnancy or breastfeeding.\n* Known hypersensitivity or allergy to any of the ingredients of the study product \"Collagendep Pink Beauty\" (e.g., collagen, hyaluronic acid, herbal extracts).\n* Concurrent use of other oral supplements that might interfere with the evaluation of the study results.\n* Patients with oncological pathologies (malignancies) in the vulvar area.\n* Inability to guarantee adequate follow-up or compliance with the treatment regimen.","18 Years",{"count":64,"type":22},40,[25],"This randomized, interventional study evaluates the efficacy of Collagendep Pink Beauty, an oral nutritional supplement, in reducing vulvar dryness in women with Genital Lichen Sclerosus (VLS) who are undergoing fat grafting treatment. Lichen sclerosus is a chronic inflammatory condition that leads to tissue hardening, loss of elasticity, and significant symptoms such as itching, pain, and dryness, which severely impact functional and emotional well-being. While fat grafting is a recognized regenerative therapy for stabilizing the disease, this study investigates whether a 4-month course of bioactive collagen peptides and functional ingredients can further improve mucosal hydration and symptom relief compared to fat grafting alone.",[68,28],"Vulvar Lichen Sclerosus",[70,71,72,73,74,35],"Lichen Sclerosus","Regenerative Medicine","Collagen Peptides","Vulvar Dryness","Hyaluronic Acid","NOT_YET_RECRUITING","2026-02-27",{"date":78,"type":45},"2026-03-04",{"date":80,"type":22},"2026-02-20",{"date":82,"type":22},"2027-02-20",{"name":84,"class":85},"San Gallicano Dermatological Institute IRCCS","OTHER",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":53},"100594839","clinical-and-molecular-study-to-evaluate-the-effect-of-the-pixel-co2-laser-femilifttm-for-the-treatment-of-vulvo-vaginal-atrophy-100594839","NCT07024667","Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy","Clinical and Molecular Study to Evaluate the Effect of the Pixel CO2 Laser (FemiLiftTM) for the Treatment of Vulvo-Vaginal Atrophy (VVA)","VVA PAP POPQ","Inclusion Criteria:\n\n1. Female 45-75 years of age, at the time of enrolment.\n2. Provided written informed consent.\n3. Spontaneous induced menopause as defined by one of the followings:\n\n   * Amenorrhea of ≥12 months\n   * After bilateral oophorectomy\n   * FSH levels\\>30 IU\n4. One or more VVA related symptoms (i.e., itching, dryness, burning, pain, dyspareunia, or dysuria), after other possible causes of these complaints have been excluded.\n5. Characteristic atrophic changes (see above) on gynaecological examination.\n6. Normal Papanicolaou (PAP) smear test from the last 3-5 years: if needed and as indicated according to the Israeli guidelines.\n7. Negative urine analysis test - urine stick.\n8. Asymptomatic for bacterial or fungal vaginitis.\n9. Vaginal canal, introitus and vestibule free of injuries and bleeding.\n10. Able and willing to comply with the treatment\u002F follow-up schedule and requirements.\n11. Normal general gynecological exam from the last year including US.\n\nExclusion Criteria:\n\n1. Vaginal Health Index Score (VHIS) \\\u003C 5.\n2. Active genital infection.\n3. Vaginal bleeding which did not underwent evaluation.\n4. Previous vulvar, vaginal or cervical dysplasia, within the last 2 years, or previous cancer.\n5. Recurring urinary tract infection or recurring infection of genital herpes (≥ 3 episodes in the recent year).\n6. Pelvic Organ prolapse (POP) \\>II, according to the pelvic organ prolapse quantification system (POP-Q).\n7. Serious systemic disease or any chronic condition that could interfere with study compliance.\n8. Any local, systemic and\u002For chronic autoimmune infection.\n9. Taken part in a clinical trial concerning VVA, within 30 days prior to the enrolment.\n10. Allergy to lidocaine or tetracaine.\n11. Genital skin disease that may interfere with the treatment (these subjects should be included\u002Fexcluded according to the investigator's discretion).\n12. Use of anticoagulants, within 5 days prior to enrolment.\n13. Active positive HPV test.\n14. Active positive HSV (Acute or actively present within the last 2 months).\n15. Heavy smoker (\\>1 pack of cigarettes a day)\n16. Any disease or medication that may interfere with the wound healing\u002Fimmune function.\n17. Pregnancy \u002F breast feeding.\n18. Any other reason that, in the opinion of the investigator, prevents the subject from participating in the study or compromise the subject safety.","45 Years","75 Years",{"count":97,"type":22},20,[25],"Vulvo Vaginal Atrophy (VVA) refers to the changes in the vaginal and vulvar surfaces that occurs during menopause due to the progressive loss of estrogen. The low levels of circulating estrogen produce a wide variety of anatomic, physiologic, and clinical changes in the urogenital area. Clinical symptoms include vaginal dryness, irritation, soreness, dyspareunia, dysuria, and vaginal discharge.\n\nIn recent years, microablative fractional CO2 laser has become available for treating vaginal atrophy. It showed a regenerative property with significant histological changes in cellular and connective tissue components. Treatment with the fractional CO2 laser resulted in restoration of the vaginal epithelium with ultrastructural findings, similar to a premenopausal state, that included thickened stratified squamous epithelium with increased collagen support, increased glycogen in epithelial cells, increased fibroblasts, increased vascularity, and presence of sub-epithelial papillae.",[28,101],"Vaginal Atrophy","2025-06-09",{"date":104,"type":45},"2025-06-17",{"date":106,"type":45},"2022-09-02",{"date":108,"type":22},"2027-12-31",{"name":110,"class":111},"Hillel Yaffe Medical Center","OTHER_GOV",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":17,"minAge":62,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100541739","evaluation-of-the-safety-and-efficacy-of-hyaluronic-acid-injection-in-labia-majora-augmentation-100541739","NCT06333782","Evaluation of the Safety and Efficacy of Hyaluronic Acid Injection in Labia Majora Augmentation","Prospective, Multicentric, Single Blind, Randomized Study on the Evaluation of the Safety and Efficacy of Genefill Contour® Versus Comparator in Labia Majora Augmentation","Inclusion Criteria:\n\n* Gender: female.\n* Age: more than 18 years old.\n* Patient affected by labia majora atrophy\u002Fhypotrophy as per investigator's judgement and expressing the wish for volume augmentation of the labia majora.\n* Patient able to understand and sign the informed consent for study enrolment.\n* Patient having given freely and expressly her informed consent.\n* Patient affiliated to a health social security system.\n* Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before inclusion and during all the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman or planning a pregnancy during the study\n* Women who gave birth within 4 months before inclusion.\n* Patient who had been deprived of their freedom by administrative or legal decision or who is under guardianship.\n* Patient in a social or sanitary establishment.\n* Patient suspected to be non-compliant according to the investigator's judgment.\n* Patient suffering from a severe or progressive disease.\n* Patient with history of auto immune disease.\n* Patient immunosuppressed.\n* Patient suffering of haemostatic disorder.\n* Patient presenting with acute or chronic skin diseases.\n* Patient is prone to active inflammatory or infectious processes or presenting clinical signs of inflammation in or close to the labia majora.\n* Patient presenting bacterial, fungal or viral infection in or close to labia majora.\n* Patient with history of streptococcal disease.\n* Patient with recurrent genital herpes (several times a year). A patient asymptomatic in the 6 months before inclusion is eligible.\n* Patient with history of pre-cancerous condition or cancer in areas close to the injection site (external urogenital, anal or vaginal).\n* Patient with an actual cancer or presence of pre-cancerous cells (vulvar dysplasia).\n* Patient with a known tendency to develop keloid or hypertrophic scars.\n* Patient with known allergy or hypersensitivity to hyaluronic acid or to one of Genefill Contour, Desirial® Plus, anesthesia (if applicable) and disinfectant components.\n* Patient with multiple allergies.\n* Patient with a condition or receiving a medication which, in the investigator's judgment, put the patient at undue risk.\n* Patient who started oestrogen therapies for treatment of vulvovaginal symptomatology within 3 months before inclusion.\n* Patient under treatment for bacterial, fungal or viral infection.\n* Patient under treatment with aspirin, anticoagulant, platelets aggregation inhibiting drugs, NSAIDs, immunosuppressive therapy and Vitamin C or treated within one week before inclusion.\n* Patient under local hydrating treatment within four weeks before inclusion.\n* Patient with history of correction with another resorbable implants with a similar indication within 12 months before inclusion.\n* Patient with history of correction with permanent implants including fat graft or semi-permanent in the area of injection.\n* Patient who underwent a surgery on labia minora within 12 months before inclusion.\n* Patient who underwent a surgery on labia majora at any time.\n* Patient having intolerance to gram-positive bacteria.",true,{"count":121,"type":22},110,[25],"The goal of this interventional clinical investigation using Genefill Contour® CE marked device outside of its indication is to compare with other hyaluronic acid device already marketed for labia majora augmentation in women with labia majora hypotrophy\u002Fatrophy.\n\nThe primary objective is the evaluation of the safety of Genefill Contour®. The secondary objectives is effectivenes of the investigational device (improvement of patient´s symptoms, patient´s satisfaction, sexual function \\& pain during injection).\n\nParticipants will come to a total of 8 visits (including 2 phone calls) over a period of 12 months. Participants would be enrolled in Genefill Contour® or comparator group.\n\nAn ancillary study would be conducted in a cohort of participants evaluating the increase in volume and distance between labia after HA injection",[28],[126,127,128,129],"Labia Majora Atrophy","Labia Majora Hypotrophy","Labia Majora Augmentation","Genital rejuvenation","2024-08-08",{"date":132,"type":45},"2024-08-09",{"date":134,"type":45},"2024-05-22",{"date":136,"type":22},"2025-07-01",{"name":138,"class":52},"Bioscience Cosmetics SL",3,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":119,"sex":17,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":53},"100555630","phase-3-the-efficacy-of-topical-vaginal-oxytocin-gel-in-postmenopausal-women-with-vulvovaginal-atrophy-100555630","NCT06514586","The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy","The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vuluvovaginal Atrophy: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Postmenopausal, sexually active female subject of age 47 - 65 years, at the time of randomization, willing to provide an informed consent.\n2. Physical Assessment showing vaginal atrophy (according to the following criteria: pale, smooth, or shiny vaginal epithelium, friable, epithelium showing no rugae, loss of elasticity or turgor of the skin, dryness of labia, fusion of labia minora, vulvar lesions, or erythema.) 3. Patients with at least one present symptom (ex. vaginal dryness, itching, burning, dysuria, and\u002For dyspareunia) and able to identify one symptom as the most bothersome symptom, with at least moderate severity.\n\n4\\. Vaginal smear cytology at screening showing ≤ 5% superficial cells 5. Vaginal pH \\> 5.0 at screening 6. A level of estradiol ≤ 30 pg\u002FmL and a level of Follicle Stimulating Hormone (FSH) \\> 40 milli International Units (mIU)\u002Fml at screening 7. Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and the study follow-up visits\n\nExclusion Criteria:\n\n1. Previous treatment with other local non-hormonal moisturizers\u002Fhormonal products within 1 month or use of lubricants within 1 week prior to inclusion.\n2. Women taking systemic hormone replacement or pills within the last 6 months.\n3. Current or history of endometrial hyperplasia or uterine\u002Fendometrial, breast, or ovarian cancer, or undiagnosed vaginal bleeding\n4. Any untreated urogenital infection within 14 days prior to randomization.\n5. Ongoing treatment with systemic medications for other non-related health conditions which might impact the study results and have the potential to bring about change in the vaginal environment e.g. glucocorticosteroids, antibiotics, etc.\n6. Critically ill patients.\n7. Patients with severe renal impairment (GFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2 as measured by the Cockcroft-Gault formula).\n8. Patients with known severe hepatic impairment (Child-Pugh C; 10 - 15 points), biliary cirrhosis, or cholestasis.\n9. Patients with known or suspected allergy or any contraindications to oxytocin.","47 Years","65 Years",{"count":150,"type":22},244,[152],"PHASE3","A Phase three randomized, double-blinded, study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM.",[101,30,28],[156,157,158,159],"vulvovaginal atrophy","postmenopause","vulvovaginal","atrophy","2024-07-17",{"date":162,"type":45},"2024-07-23",{"date":164,"type":22},"2024-09",{"date":166,"type":22},"2025-08",{"name":168,"class":169},"Oxagon","NETWORK",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":182,"studyType":183,"phases":4,"briefSummary":184,"conditions":185,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":53},"100507646","vulvar-disease-in-nigeria-observational-study-100507646","NCT05890092","Vulvar Disease in Nigeria Observational Study","Vulvar Disease in Nigeria - Registry ( Observationsl Study)","VdiN","Inclusion Criteria:\n\n* biological females - afab\n\nExclusion Criteria:\n\n* none-afab","10 Years","90 Years",{"count":181,"type":22},1000,"12 Months","OBSERVATIONAL","Vulvar disease in Nigeria A look at awareness within patients and health practitioners, self-reported and actual prevalence within communities in Nigeria",[186,28,187],"Vulvar Diseases","Dermatoses","2023-05-25",{"date":190,"type":45},"2023-06-06",{"date":192,"type":45},"2023-05-03",{"date":194,"type":22},"2026-11-30",{"name":196,"class":52},"KDRS ltd"]