[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vaginal-atrophy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vaginal-atrophy":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,51,97,130,159,181,211,237,261,290,312],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100468390","phase-3-testing-laser-therapy-for-treatment-of-vaginal-dryness-in-survivors-of-breast-cancer-the-revitalize-trial-100468390",false,"NCT05379153","Testing Laser Therapy for Treatment of Vaginal Dryness in Survivors of Breast Cancer, The Revitalize Trial","The Revitalize Trial: Reducing Vaginal Atrophy With Fractional CO2 Laser for Breast Cancer Survivors","Inclusion Criteria:\n\n* Women with a history of breast cancer treated with curative intent who have completed primary therapy (consisting of surgery with or without chemotherapy, targeted therapy, immunotherapy and\u002For radiation) \\>= 12 months prior to registration. Concurrent trastuzumab \u002Fpertuzumab is permissible\n* May be receiving ongoing adjuvant endocrine therapy (with an AI or tamoxifen +\u002F- ovarian function suppression). Patients are not required to receive these treatments to be eligible. Participants receiving adjuvant endocrine therapy prior to registration must intend to continue the same endocrine therapy for the 4 months while they are receiving protocol treatment, unless a clinically necessary change is indicated at the discretion of the patient's medical oncologist. Patients on aromatase inhibitor (AI) therapy, tamoxifen with or without ovarian function suppression therapy must have been on their current endocrine therapy regimen for at least 6 months prior to registration\n* Patient-reported vaginal dryness with or without dyspareunia of at least moderate severity on average, defined as \\>= 4 on a 0-10-point scale that has been bothersome for \\>= 3 months and for which the patient wants to undergo the study procedure\n* No evidence of metastatic breast cancer. Scans to assess for metastatic disease are not required for eligibility\n* No prior gynecologic cancer, vaginal intra-epithelial neoplasia, pelvic radiation or pelvic reconstructive surgery utilizing mesh. Patients with cervical intraepithelial neoplasia are eligible\n* No history of scleroderma, lupus, systemic sclerosis, mixed connective tissue disorder, undifferentiated connective tissue disorder or collagen vascular disease, dermatomyositis, polymyositis, lichen sclerosis or vulvar vestibulitis\n* No pelvic surgery that involved a vaginal incision within 6 months of registration. Patients who received laparoscopic BSO (Bilateral salpingooophorectomy) are eligible\n* No systemic estrogen or progesterone, vaginal estrogen, vaginal prasterone, ospemifene, and\u002For androgen therapy within 6 weeks prior to registration\n* No other suspected contraindications for undergoing laser therapy\n* No prior vaginal laser therapy at any time. Patients who would have completed any type of vaginal laser resurfacing procedure at any time prior to the start of study treatment are not eligible\n* No known concurrent invasive carcinoma\u002Fmalignancy. Patients with carcinoma in situ are eligible. Patients with a prior malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible if not currently receiving treatment\n* Postmenopausal based on at least one of the following criteria at the time of registration:\n\n  * Women 50 or older with no spontaneous regular menses \\> 12 months\n  * On ovarian suppression (i.e., gonadotrophin releasing hormone \\[GNRH\\] agonist\u002Fantagonist) for at least 6 months or greater, with plans to continue such treatment for at least 18 weeks\n  * Bilateral oophorectomy\n  * Women on AI therapy (i.e., clinically judged to be postmenopausal)\n* In order to complete the mandatory patient-completed measures, participants must be able to speak, read and understand English or Spanish\n* Age \\>= 22 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* No medical history of: keloid formation, genital fistula, thin recto-vaginal septum (defined as a distance of \\\u003C 2 cm between the vaginal opening and the anal opening)","FEMALE","22 Years",{"count":19,"type":20},250,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This phase III trial tests whether vaginal fractional CO2 laser therapy works in treating vaginal dryness in breast cancer survivors. Vaginal dryness can be commonly experienced with normal aging, with menopause, or come about from medications used to treat breast cancer such as chemotherapy or endocrine therapies like tamoxifen or aromatase inhibitors. Vaginal fractional CO2 laser therapy may help reduce vaginal dryness.",[26,27,28,29,30,31,32,33,34,35,36,37],"Anatomic Stage 0 Breast Cancer AJCC v8","Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage IA Breast Cancer AJCC v8","Anatomic Stage IB Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage IIA Breast Cancer AJCC v8","Anatomic Stage IIB Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IIIA Breast Cancer AJCC v8","Anatomic Stage IIIB Breast Cancer AJCC v8","Anatomic Stage IIIC Breast Cancer AJCC v8","Vaginal Atrophy","RECRUITING","2026-05-07",{"date":41,"type":42},"2026-05-11","ACTUAL",{"date":44,"type":42},"2026-04-21",{"date":46,"type":20},"2027-05",{"name":48,"class":49},"Alliance for Clinical Trials in Oncology","OTHER",2,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":16,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":73,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100633458","phase-4-vaginal-estradiol-vs-moisturizer-to-improve-postmenopausal-vaginal-aging-symptoms-and-the-microbiome-in-women-living-with-hiv-100633458","NCT07526948","Vaginal Estradiol vs Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms and the Microbiome in Women Living With HIV","Vaginal Estradiol Versus Moisturizer to Improve Postmenopausal Vaginal Aging Symptoms, Dysbiosis and Markers of Latency Reversal in Menopausal Women Living With HIV","Inclusion Criteria:\n\n* female\n* at least 40 years old\n* menopausal (no menses in 12 months) within 2 years of last menstrual period or perimenopausal in the late menopausal transition, defined as an interval of amenorrhea greater than or equal to 60 days\n* have symptoms of the genitourinary syndrome of menopause (GSM) which developed within the prior 2 years. Symptoms of GSM include vaginal symptoms including dryness, soreness, itching, irritation and dyspareunia and\u002For urinary symptoms including urgency, frequency and recurrent urinary tract infections (UTIs)\n\nExclusion Criteria:\n\n* Unexplained or unevaluated abnormal genital bleeding\n* Current or suspected pregnancy\n* Desired pregnancy\n* If less than 55 years old, have had a hysterectomy and have at least one ovary (as menopause cannot be determined in this case by amenorrhea alone)\n* Pelvic or vaginal surgery in the prior 60 days\n* Used systemic reproductive hormones in the last 2 months\n* Used antibiotics in the last 30 days\n* Used immunosuppressive medications in the prior 60 days including biologics, chemotherapeutics or post transplant immunosuppressive medications\n* Used any vaginal or vulvar preparations in the last month\n* Current active vaginal infection diagnosed at study entry\n* Any serious disease or condition that may interfere with study compliance\n* Current or previous history of breast cancer or estrogen dependent cancer (e.g., ovarian, endometrial)\n* Current or previous history of deep vein thrombosis or pulmonary embolism\n* Current or previous history of myocardial infarction or stroke\n* Known clotting disorder including Protein C, Protein S and antithrombin deficiency, Factor V Leiden or prothrombin mutations\n* Known severe liver disease including cirrhosis or active Hepatitis B\n* Known allergic reaction to Vagifem (estradiol vaginal tablet) or Replens",true,"40 Years","70 Years",{"count":62,"type":20},62,[64],"PHASE4","This is a research study about the effects of vaginal estradiol compared to moisturizer on vaginal symptoms of menopause and the microbiome in women with HIV. This research study aims to understand how vaginal products affect the aging of the female genital tract in women living with HIV who are menopausal or perimenopausal and have vaginal or urinary symptoms. There is a comparison group of women who are living without HIV. Participants with HIV and vaginal or urinary menopausal symptoms (e.g., dryness, irritation, soreness, itching, pain with sex, dysuria, urgency, or frequent urinary tract infections) will be asked to apply vaginal estradiol or a vaginal moisturizer (Replens). Participants who have vaginal or urinary menopausal symptoms and do not have HIV will receive vaginal estradiol.",[67,37,68,69,70,71,72],"Menopausal Complaints","Genitourinary Symptoms","HIV (Human Immunodeficiency Virus)","Menopause Related Conditions","Vaginitis","Perimenopause",[74,75,76,77,78,79,80,81,82,83,84,85],"Pain with sex","Vaginal dryness","Symptoms of menopause","HIV Infection","Menopause","Vaginal microbiome","Dysbiosis","Aging","Premature aging","Atrophic vaginitis","Genitourinary syndrome of menopause (GSM)","Symptoms of perimenopause","NOT_YET_RECRUITING","2026-04-08",{"date":89,"type":42},"2026-04-14",{"date":91,"type":20},"2026-06-01",{"date":93,"type":20},"2031-06-30",{"name":95,"class":49},"Albert Einstein College of Medicine",1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":21,"phases":108,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":96},"100474443","phase-4-postpartum-vaginal-estrogen-for-breastfeeding-patients-100474443","NCT05457972","Postpartum Vaginal Estrogen for Breastfeeding Patients","Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age 18 or older\n* Sexually active\n* Singleton, term (37 weeks 0 days) birth\n* Planning to breastfeed or pump during the study period\n* History of successful breastfeeding or pumping after a prior pregnancy\n* Between 6 weeks and 6 months postpartum (patients may be recruited at any time during the postpartum period, but the study period will not start until 6 weeks postpartum)\n* Ability to consent in English\n* Not meeting any exclusion criteria\n\nExclusion Criteria:\n\n* Preterm delivery\n* Perinatal mortality\n* History of difficulty breastfeeding\n* 3rd or 4th degree perineal laceration\n* Any contraindications to estrogen, including, but not limited to, breast cancer or a history of breast cancer, estrogen-dependent neoplasia, active deep vein thrombosis (DVT)\u002Fpulmonary embolism (PE) or a history of these conditions, active arterial thromboembolic disease (for example, stroke and MI) or a history of these conditions, known anaphylactic reaction, angioedema, or hypersensitivity to estrogen, hepatic impairment or disease, protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.","18 Years","50 Years",{"count":107,"type":20},100,[64],"Sexual dysfunction is very common in the postpartum period and is more common in people who breastfeed or pump. This research study was designed to help determine whether postpartum patients who use vaginal estrogen cream while breastfeeding have improved sexual function compared to postpartum patients who do not.",[111,112,37],"Breastfeeding","Postpartum Sexual Dysfunction",[114,115,116,117,118,119,120],"vaginal atrophy","postpartum","sexual dysfunction","dyspareunia","breastfeeding","pumping","vaginal dryness","2026-03-06",{"date":123,"type":42},"2026-03-10",{"date":125,"type":42},"2025-02-22",{"date":127,"type":20},"2026-09-30",{"name":129,"class":49},"University Hospitals Cleveland Medical Center",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":158},"100512487","valor-vaginal-atrophy--long-term-observation-of-recovery-100512487","NCT05953090","VALOR: Vaginal Atrophy & Long-term Observation of Recovery","VALOR","Inclusion Criteria:\n\n* Diagnosed atrophic vaginitis, lichen sclerosus, lichen simplex chronicus or lichen planus\n* Continuous vulvovaginal symptoms\n* Access to smartphone and tablet, laptop or computer\n* Access to a valid email address\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Patient unable to apply topical device\n* Allergy or intolerance to ingredients or excipients of the formulation of studied products\n* Systemic hormonal therapy started less than 30 days before baseline\n* Systemic corticosteroids ongoing treatment or used within the last 30 days before baseline\n* Ongoing topical HRT or corticosteroid treatment for the indication under investigation\n* Topical HRT or corticosteroid treatment used for the indication under investigation within the last 30 days before baseline",{"count":138,"type":20},2000,[140],"NA","Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.",[143,37,144,145,146,147],"Atrophic Vaginitis","Genitourinary Syndrome of Menopause","Lichen Sclerosus of Vulva","Lichen Planus of Vulva","Lichen Simplex of Vulva (Disorder)","2026-02-19",{"date":150,"type":42},"2026-02-20",{"date":152,"type":42},"2023-10-30",{"date":154,"type":20},"2028-12",{"name":156,"class":157},"Stratpharma AG","INDUSTRY",14,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":96},"100619566","phase-4-assist-vla-assessment-of-symptom-specific-improvement-in-diagnosed-vaginal-atrophy-following-laser-therapy-100619566","NCT07346287","ASSIST-VLA: Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy","Assessment of Symptom-Specific Improvement in Diagnosed Vaginal Atrophy Following Laser Therapy (ASSIST-VLA)","ASSIST-VLA","Inclusion Criteria:\n\n* Diagnosed vaginal atrophy\n* Access to smartphone and tablet, laptop or computer\n* Access to a valid email address\n* Previously completed laser therapy session schedule\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Patient unable to apply topical device\n* Allergy or intolerance to ingredients or excipients of the formulation of studied products\n* Systemic hormonal or steroidal therapy started less than 30 days before baseline ( = not yet on a stable regimen)",{"count":168,"type":20},10,[64],"Vaginal atrophy patients receiving vaginal laser therapy will be treated with daily 7-0940® following a laser session to evaluate the safety and efficacy of the product as an adjunct treatment. Clinical outcomes will be assessed using validated investigator- and patient-reported measures, with safety and symptom progression monitored throughout the study.",[37,143,172],"Genitourinary Syndrome of Menopause (GSM)","2026-01-15",{"date":175,"type":42},"2026-01-16",{"date":177,"type":42},"2025-08-13",{"date":179,"type":20},"2026-04",{"name":156,"class":157},{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":58,"sex":16,"minAge":189,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":197,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":96},"100424514","phase-4-prevention-of-recurrent-uti-using-vaginal-testosterone-versus-placebo-placebo-100424514","NCT04807894","Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo","Prevention of Recurrent Urinary Tract Infection Using Vaginal Testosterone Versus Placebo","PIVoT","Inclusion Criteria:\n\n* 60-90 yo Female\n* Postmenopausal\n* Recurrent UTIs (three or more culture confirmed symptomatic episodes of UTI or two or more in the past 6 months).\n* English Proficiency\n* Unable or unwilling to use topical estrogen.\n* Patients with history of or current endometrial or breast cancer and current aromatase inhibitor therapy may also be included in study.\n* Patient on oral estrogen therapy may be included.\n* Patient with slings, prior vaginal surgery or pessary may be included.\n\nExclusion Criteria:\n\n* Current UTI\u002F Dipstick and culture positive (\\> trace leukocytes or nitrites)\n* Antibiotic (vaginal or oral) use in the last 4 weeks\n* Current sexually transmitted infection\n* Chronic Foley catheter use or chronic ureteral stent placement.\n* Vaginal probiotic use in the last 4 weeks\n* Patient currently using vaginal estrogen.\n* Post-void Residual Volume \\>150 mL or current diagnosis of urinary retention\n* Non-evaluated hematuria (\\> trace on dipstick, microscopic, gross)\n* Unable to complete study tasks or comply with follow up.","60 Years","90 Years",{"count":107,"type":20},[64],"Women over the age of 60 years have an estimated 10 to 15 % risk of recurrent urinary tract infections (UTI). This is believed to be due to hormonally induced changes in the vaginal flora associated with menopause. After menopause, there is a chemical changes in the vagina that may predispose to bacterial infections.\n\nThe role of vaginal estrogen creams to restore vaginal atrophy and prevent urinary tract infections has been well characterized. Vaginal testosterone (VT) application use in postmenopausal breast cancer patients on aromatase inhibitors have been shown to improve vaginal pH, vaginal atrophy symptom scores, dyspareunia, and vaginal dryness. Although testosterone has been used to improve sexual function in postmenopausal women, the effects of VT on vaginal flora and recurrent UTIs are unknown.\n\nThe purpose of this study is to determine whether topically applied vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections and to ascertain the effects of topical estrogen on the vaginal pH and flora.",[195,37,196],"Recurrent Urinary Tract Infection","Postmenopausal Disorder",[198,199,200,201],"urinary tract infections,","postmenopausal women","vaginal atrophy,","vaginal flora","2025-11-04",{"date":204,"type":42},"2025-11-05",{"date":206,"type":42},"2020-11-01",{"date":208,"type":20},"2026-12-31",{"name":210,"class":49},"Maimonides Medical Center",{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":219,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":96},"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":222,"type":20},20,[140],"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.",[226,37],"Vulvar Atrophy","2025-06-09",{"date":229,"type":42},"2025-06-17",{"date":231,"type":42},"2022-09-02",{"date":233,"type":20},"2027-12-31",{"name":235,"class":236},"Hillel Yaffe Medical Center","OTHER_GOV",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":16,"minAge":219,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":247,"phases":4,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":96},"100476415","compare-vaginal-estrogen-and-platelet-rich-plasma-over-women-with-genitourinary-syndrome-of-menopause-100476415","NCT05483634","Compare Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause","Compare the Effectiveness and Side Effects of Vaginal Estrogen and Platelet-rich Plasma Over Women With Genitourinary Syndrome of Menopause","Inclusion Criteria:\n\n* Women with menopause\n* Patients with symptoms of genitourinary syndrome of menopause\n\nExclusion Criteria:\n\n* Genitourinary bleeding or infection without definitive diagnosis\n* Coagulopathy\n* Allergy to medication or therapy related with the treatment\n* Chronic disease that might influence outcome\n* Using medication that might influence outcome in 30 days\n* Using hormone or steroid within 8 weeks","80 Years",{"count":246,"type":20},40,"OBSERVATIONAL","The definition of Genitourinary Syndrome of Menopause (GSM) is the decline of estrogens during menopause results in symptoms and clinical signs from both systems. Estrogen and other hormones production decrease after menopause because the ovaries lose their effectiveness, leading to mucosal atrophy, reduced vaginal moisture, dysuria, urgency, recurrent infection, burning, pruritus and dyspareunia.\n\nThe treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet rich plasma, etc. Observational cohort study will be used for study design, and questionnaire, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used for evaluation of the effectiveness and side effects.",[78,250,251,37],"Platelet-rich Plasma","Estrogen Replacement Therapy","2025-05-06",{"date":254,"type":42},"2025-05-09",{"date":256,"type":20},"2025-12-01",{"date":258,"type":20},"2027-06-30",{"name":260,"class":49},"Mackay Memorial Hospital",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":58,"sex":16,"minAge":59,"maxAge":220,"enrollmentInfo":268,"targetDuration":4,"studyType":21,"phases":270,"briefSummary":271,"conditions":272,"keywords":275,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":288,"locationsCount":96},"100465024","treatment-of-vaginal-atrophy-with-low-intensity-nanosecond-neodymium-laser-100465024","NCT05335317","Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser","Study of the Efficiency and Safety of Low-Intensity Neodymium Laser Radiation With a Nanosecond Pulse Duration for Treatment of the Vaginal Walls Atrophic Changes","Inclusion Criteria:\n\n* Age of 40-75 years, inclusive;\n* Vaginal atrophy or 1st grade vaginal prolapse with atrophy, or lack of vaginal atrophy in case of control group 2;\n* All participants have informed consent to conduct a course of procedures according to protocol, carry out follow-up visits, and conduct studies.\n\nExclusion Criteria:\n\n* Age of under 40 and over 75 years old;\n* History of oncological diseases;\n* Active tuberculosis;\n* Inflammatory diseases of the vulva and vagina including genital herpes in the acute stage;\n* Urinary tract infections;\n* Damage to the vaginal mucosa;\n* Pregnancy;\n* Tendency to photoallergy including taking photosensitizing drugs (diuretics, antihistamines, antipsychotics);\n* Porphyria;\n* Cardiac deficiency of 2-3 degrees;\n* Chronic renal disease;\n* Participants with greater than 1st grade vaginal prolapse;\n* Women after childbirth up to 8 weeks;\n* Participants who, according to the doctor, are not able to complete the study;\n* Protocol non-compliance of laser exposure sessions;\n* Voluntary refusal to participate in the study;\n* Violation of recommendations for the management of the period after laser treatment;\n* Adverse events that occurred during laser processing and research, and associated with them.\n* The appearance of contraindications listed in the Exclusion criteria.",{"count":269,"type":20},120,[140],"The aim of study is characteristic of changes in the vaginal wall after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls before and after laser treatment, the following methods will be used: vaginal health index, perineometry, measurement of the vaginal wall thickness by ultrasound, Doppler sonography of the vaginal walls vessels, optical coherence tomography, biopsy, cytological and immunocytochemical methods. The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality. Total up to 100 participants with and 20 participants without postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment (study group), topical hormones treatment (control group 1) and no treatment (control group 2) by 70, 30 and 20 participants in each group respectively. The time intervals between special tests and the tests themselves will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment of the vaginal atrophy and normal condition without treatment will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the control group.",[273,37,274],"Postmenopausal Period","Vaginal Prolapse",[37,274,276,277,278,279,280,281],"Neodymium Laser","Laser Treatment","Nanosecond","Laser","Vaginal","Postmenopausal","2024-12-09",{"date":284,"type":42},"2024-12-12",{"date":286,"type":42},"2022-04-18",{"date":256,"type":20},{"name":289,"class":157},"MeLSyTech, Ltd",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":4},"100559496","phase-3-hydration-and-acceptability-of-the-genital-and-skin-mucosa-of-a-vaginal-moisturizer-in-menopausal-women-100559496","NCT06564883","Hydration and Acceptability of the Genital and Skin Mucosa of a Vaginal Moisturizer in Menopausal Women","Clinical Evaluation of Hydration and Acceptability of the Genital and Cutaneous Mucosa of a Vaginal Moisturizer in Vaginal Dryness in Menopausal Women","Inclusion Criteria:\n\n* Healthy research participants, with an active sexual life;\n* Intact skin and mucosa in the test region;\n* Participants vaccinated for COVID-19 (Corona virus Disease).\n* Agreement to adhere to the study procedures and requirements and attend the institute on the day(s) and time(s) determined for the assessments;\n* Ability to consent to participate in the study;\n* Menopausal participants of any age, without systemic or topical hormone replacement therapy in the last 6 months\n* Presenting mild to moderate vaginal dryness (≥0.5 and \\\u003C7.5) - according to the Visual Analogic Scale\n* Healthy research participants, with an active sex life (at least once a week)\n\nExclusion Criteria:\n\n* Skin pathology in the area of product application;\n* Decompensated Diabetes Mellitus (TBD by the institute together with the sponsor);\n* Immune insufficiency;\n* Current use of the following topical or systemic medications: corticosteroids, immunosuppressants and antihistamines;\n* Skin diseases: vitiligo, psoriasis, atopic dermatitis;\n* Previous reaction to the category of the product tested;\n* Other illnesses or medications that may directly interfere with the study or put the health of the research participant at risk.\n* Have used vaginal moisturizing creams and\u002For intimate lubricants 5 days before the initial study visit;\n* Have had sexual intercourse at least 48 hours before the initial study visit;\n* Have been diagnosed with a urogenital or vaginal infection in the last 30 days;\n* Have used topical or systemic antibiotics, antifungals, hormone-based creams or treatment for vaginal atrophy in the last 30 days.",{"count":298,"type":20},45,[23],"Hyaluronic Acid is indicated for the relief of vaginal dryness, itching, and irritation, or the reduction of vaginal lubrication with prolonged hydration effects for up to 72 hours. Hyaluronic Acid promotes vaginal moisture, providing symptom relief in various situations such as:\n\n* Vaginismus and other sexual dysfunctions related to penetration\n* Users of hormonal contraceptives with lubrication loss\n* Postpartum and lactational period\n* Post antibacterial or antifungal therapies\n* During systemic oncological treatments (chemotherapy, radiotherapy, hormone therapy)\n* Climacteric (urogenital atrophy)\n* Post urogynecological surgeries (correction of urinary incontinence, genital dystopias, etc.)\n* Post vulvovaginal abrasive, chemical, laser, or high-frequency therapies\n* Post cosmetic and genital rejuvenation therapies",[302,37,78],"Vaginismus","2024-08-19",{"date":305,"type":42},"2024-08-21",{"date":307,"type":20},"2025-03-01",{"date":309,"type":20},"2025-10-30",{"name":311,"class":157},"Biolab Sanus Farmaceutica",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":58,"sex":16,"minAge":319,"maxAge":320,"enrollmentInfo":321,"targetDuration":4,"studyType":21,"phases":323,"briefSummary":324,"conditions":325,"keywords":326,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":96},"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":322,"type":20},244,[23],"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.",[37,144,226],[327,328,329,330],"vulvovaginal atrophy","postmenopause","vulvovaginal","atrophy","2024-07-17",{"date":333,"type":42},"2024-07-23",{"date":335,"type":20},"2024-09",{"date":337,"type":20},"2025-08",{"name":339,"class":340},"Oxagon","NETWORK"]