[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"genitourinary-syndrome-of-menopause-gsm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:genitourinary-syndrome-of-menopause-gsm":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,54,81,113,139,165,192,224],{"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},"100054200","photobiomodulation-for-vaginal-dysfunctions-home-based-vs-outpatient-treatment-100054200",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":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":63,"targetDuration":65,"studyType":66,"phases":4,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":53},"100636279","determining-the-extent-of-the-genitourinary-syndrome-of-menopause-burden-in-breast-cancer-survivors-100636279","NCT07563621","Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors","Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors: a Cohort Study","V-light cohort","Inclusion Criteria:\n\n* Women diagnosed with breast cancer stage 0, I, II, and III\n* Prior to CT\u002FET, receiving only one of both (no combination)\n* Age 18 years or above\n* Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)\n* Dutch-speaking (be able to understand the informed consent and study-related questionnaires)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Concomitant CT and ET treatment\n* Structural restorative therapies, such as photobiomodulation therapy (PBM) and fractional CO₂ laser treatment, are not permitted during the study period. During the study period, only symptomatic treatment of GSM (e.g., vaginal lubricants or moisturizers) will be allowed",true,{"count":64,"type":21},264,"12 Months","OBSERVATIONAL","Breast cancer survivors (BCS) often face unique challenges during and after treatment, including the onset of menopause-related symptoms. Genitourinary Syndrome of Menopause (GSM) is a common concern in BCS undergoing endocrine therapy (ET). It is a chronic condition caused by estrogen deficiency, leading to vaginal and urinary symptoms such as dryness, irritation, pain during intercourse, recurrent infections, and urinary urgency.\n\nThe prevalence of GSM in BCS varies widely depending on factors such as the type of ET, individual patient characteristics, and the duration of treatment. As such, the prevalence of GSM in BCS can range from 13% to 95.2%. A recent systematic review performed by part of the investigators of this study concludes that GSM is a significant problem for breast cancer patients. However, most studies lack a control group, limiting the results' validity. Therefore, this study aims to determine the extent of the GSM burden in BCS using a prospective, controlled cohort study. This study will compare breast cancer patients receiving endocrine therapy (ET) with those undergoing chemotherapy (CT), as CT may also induce GSM-like symptoms. In addition, a comparison will be made with healthy controls.\n\nFor this study, two groups of participants are included: women with breast cancer and a healthy control group without breast cancer. Within the breast cancer group, a distinction is made between women receiving chemotherapy only and women undergoing hormone therapy only. All participants complete questionnaires. The control group completes these questionnaires once, whereas women with breast cancer are asked to complete the same questionnaires at multiple time points during their treatment and follow-up. This longitudinal approach allows us to assess how potential symptoms evolve over the course of treatment. By comparing responses between both groups, a clearer understanding of which symptoms occur more frequently in women with breast cancer as a consequence of their treatment can be obtained.",[27,69,70,35],"Breast Cancer","Vulvovaginal Atrophy","RECRUITING","2026-04-29",{"date":74,"type":45},"2026-05-04",{"date":76,"type":45},"2026-03-05",{"date":78,"type":21},"2028-08-31",{"name":80,"class":52},"Jessa Hospital",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":53},"100625161","bipolar-radiofrequency-for-genitourinary-syndrome-of-menopause-100625161","NCT07419035","Bipolar Radiofrequency for Genitourinary Syndrome of Menopause","Efficacy of Bipolar Radiofrequency for Genitourinary Syndrome of Menopause in Postmenopausal Women: A Randomized, Sham-Controlled Clinical Trial","BRF-GSM","Inclusion Criteria:\n\n* Women aged 40 to 65 years\n* Postmenopausal status\n* Presence of at least one symptom of genitourinary syndrome of menopause (e.g., vaginal dryness, irritation, pruritus, urinary symptoms, or dyspareunia)\n* Sexual activity at least once per month\n* Ability to understand and complete study questionnaires\n* Provision of written informed consent\n\nExclusion Criteria:\n\n* Active vaginal infection\n* Neurological, neoplastic, or sexually transmitted diseases\n* Diagnosis of vulvodynia or vaginismus\n* Pelvic organ prolapse stage II or higher\n* Pelviperineal hypoesthesia\n* Presence of pacemaker or other electronic implantable devices\n* Use of estrogen hormonal therapy within the previous 3 months\n* History of pelvic radiotherapy\n* Pelvic surgery within the previous 6 months\n* Active anticoagulant therapy\n* Previous vaginal laser or ablative vaginal rejuvenation procedures within the previous 6 months\n* Cognitive impairment preventing completion of questionnaires","40 Years","65 Years",{"count":92,"type":21},40,[24],"This randomized, sham-controlled clinical trial aims to evaluate the efficacy and safety of bipolar radiofrequency in the treatment of genitourinary syndrome of menopause (GSM) in postmenopausal women. Participants will be randomly assigned to receive either active bipolar radiofrequency treatment or a sham procedure.\n\nThe primary objective is to determine whether bipolar radiofrequency improves vaginal and sexual function. Secondary objectives include assessment of pain with vaginal penetration, vaginal lubrication and tissue distensibility, patient-reported vulvovaginal symptom severity, and treatment safety and tolerability.",[27],[97,98,99,100,101,102,103],"bipolar radiofrequency","menopause","sexual function","dyspareunia","vaginal atrophy","postmenopausal women","radiofrequency therapy","2026-02-11",{"date":106,"type":45},"2026-02-18",{"date":108,"type":21},"2026-03-15",{"date":110,"type":21},"2026-09-30",{"name":112,"class":52},"University of Castilla-La Mancha",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":53},"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":122,"type":21},10,[124],"PHASE4","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.",[127,128,27],"Vaginal Atrophy","Atrophic Vaginitis","2026-01-15",{"date":131,"type":45},"2026-01-16",{"date":133,"type":45},"2025-08-13",{"date":135,"type":21},"2026-04",{"name":137,"class":138},"Stratpharma AG","INDUSTRY",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":53},"100605254","early-phase-1-a-clinical-study-of-chinese-herbal-formula-tjaoa103-in-treating-genitourinary-syndrome-of-menopause-100605254","NCT07160127","A Clinical Study of Chinese Herbal Formula TJAOA103 in Treating Genitourinary Syndrome of Menopause","The Efficacy and Safety of Chinese Herbal Formula TJAOA103 for the Treatment of Genitourinary Syndrome of Menopause: A Prospective and Single-Arm Study","Inclusion Criteria:\n\n1. Females aged 45-70 years during the menopausal transition or postmenopausal period.\n2. Presence of at least one moderate-to-severe (score ≥ 2) symptom of GSM, including vulvovaginal dryness, or vulvovaginal itching\u002Firritation, or vulvovaginal burning\u002Fpain, or dyspareunia, or dysuria\u002Furinary frequency\u002Furgency.\n3. Willing to participate in this trial and sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Acute or recurrent genitourinary infection.\n2. Acute or chronic dermatosis of the vulva or vagina.\n3. A grade 3 or higher degree of prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.\n4. Unexplained abnormal uterine bleeding.\n5. Ovarian\u002Fadnexal mass ≥ 4 cm, or adenomyosis, or adenomyoma\u002Futerine myoma ≥ 4 cm.\n6. Breast Imaging Reporting and Data System (BI-RADS) classification of breast ultrasound ≥ 4.\n7. Presence of precancerous lesions or diagnosed malignancy.\n8. Liver or kidney function indicators (ALT, AST, Urea, Cr) exceeding the upper limits of reference ranges upon repeated testing.\n9. Severe primary diseases of the nervous, circulatory, respiratory, digestive, urinary or hematopoietic systems; or mental diseases;\n10. Known allergy to any specific ingredient of the trial drugs.\n11. Systemic hormone therapy within the past 2 months.\n12. Application of vaginal moisturizers, lubricants, hormone preparations, or alternative therapies for GSM within the past month.\n13. Current participation in another clinical trial or participation in another trial within the past month.\n14. Unwillingness to discontinue the use of moisturizers, lubricants, or any form of hormonal drugs during the trial.\n15. Other conditions deemed unsuitable for participation by the investigators.","45 Years","70 Years",{"count":149,"type":21},113,[151],"EARLY_PHASE1","The goal of this clinical trial is to learn if Chinese herbal formula TJAOA103 works to treat genitourinary syndrome of menopause (GSM). It will also learn about the safety of TJAOA103. The main questions it aims to answer are:\n\n1. Does TJAOA103 alleviate the symptoms of GSM in participants or have any other benefits?\n2. What medical problems do participants have when taking TJAOA103? Researchers will conduct a pre-post comparison to see if TJAOA103 works to treat GSM.\n\nParticipants will:\n\n1. Take TJAOA103 twice daily for 4 to 12 weeks.\n2. Complete the tests and\u002For questionnaires on schedule through online follow-up or outpatient visits.\n3. Record their use of TJAOA103 and any adverse events.",[27],[35,155],"Traditional Chinise Medicine","2025-09-10",{"date":158,"type":45},"2025-09-17",{"date":160,"type":21},"2025-09-15",{"date":162,"type":21},"2027-09-15",{"name":164,"class":52},"Tongji Hospital",{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":172,"targetDuration":4,"studyType":22,"phases":174,"briefSummary":175,"conditions":176,"keywords":177,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":53},"100595632","efficacy-of-non-ablative-radiofrequency-combined-with-pelvic-floor-muscle-training-for-genitourinary-syndrome-of-menopause-in-breast-cancer-survivors-rf-sgm-100595632","NCT07034976","Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)","Randomized, Controlled Trial to Evaluate the Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training on Symptoms of Genitourinary Syndrome of Menopause in Breast Cancer Survivors","Inclusion Criteria:\n\n* Women who are breast cancer survivors and clinically confirmed to be disease-free by their physician.\n* Amenorrhea for more than 12 months and vaginal pH ≥ 5, with symptoms related to genitourinary syndrome of menopause (GSM), as diagnosed by a physician. Symptoms must be bothersome and not better explained by another clinical condition.\n* Negative urine culture at baseline.\n* Moderate to severe vaginal dryness, defined as a score \\> 4 on the Numeric Rating Scale (NRS 0-10)\n\nExclusion Criteria:\n\n* Age over 75 years.\n* Current or past diagnosis of any cancer other than breast cancer.\n* Pelvic surgery, chemotherapy, or radiotherapy in the past 3 months.\n* Use of local estrogen therapy within the past month.\n* Active genital infections.\n* Diagnosis of HIV infection or severe immunosuppression.\n* Presence of pacemakers, metallic implants, or electromagnetic devices.\n* Coagulation disorders or current use of anticoagulants.\n* Pelvic organ prolapse stage \\> III (POP-Q classification).\n* Unexplained abnormal vaginal bleeding.\n* History of pelvic anti-incontinence surgery, with or without mesh.\n* Inflammatory dermatoses of the vulva.\n* Pelvic-floor muscle strength score of 0\u002F5 on the Modified Oxford Scale.\n* Nickel allergy.\n* Previous treatment with radiofrequency in the pelvic or genital area.",{"count":173,"type":21},50,[24],"The goal of this clinical trial is to find out whether non-ablative radiofrequency (RF) applied together with pelvic-floor muscle exercises can ease vaginal dryness and other symptoms of genitourinary syndrome of menopause (GSM) in women aged 18-75 years who have survived breast cancer and currently experience those symptoms.\n\nThe main questions it aims to answer are:\n\nDoes the combination of RF + exercise lower the 0-to-10 vaginal-dryness score more than sham (inactive) RF + exercise at 6 weeks (end of treatment) and 3 months?\n\nWhat other changes (pain during intercourse, Vaginal Health Index, urinary and sexual function, pelvic-floor strength, overall satisfaction) are seen in each group?\n\nResearchers will compare six sessions of active RF with six sessions of sham (inactive) RF to see whether the active treatment works better.\n\nParticipants will:\n\nVisit the hospital once a week for 6 weeks. Each visit includes about 20 minutes of intra-\u002Fextra-vaginal RF (or sham) and 20 minutes of guided pelvic-floor training whose content is adapted and progressed throughout the study.\n\nCarry out a structured, progressive home-exercise programme, recording any discomfort in a diary.\n\nComplete questionnaires and tests at baseline, after session 6, and 3 months later.",[27,69],[178,101,179,180,181,182,183],"genitourinary syndrome of menopause","vaginal dryness","breast cancer survivors","non-ablative radiofrequency","pelvic floor muscle training","physiotherapy","2025-09-09",{"date":160,"type":45},{"date":187,"type":45},"2025-09-01",{"date":189,"type":21},"2027-12-31",{"name":191,"class":52},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":200,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":222,"locationsCount":53},"100571567","genitourinary-syndrome-of-menopause-in-breast-cancer-100571567","NCT06721936","Genitourinary Syndrome of Menopause in Breast Cancer","Genitourinary Syndrome of Menopause Induced by Breast Cancer Treatments: A Randomized Clinical Trial Protocol Comparing Multimodal Pelvic Floor Physiotherapy and Frac-tional CO2 Laser Therapy (PILME Study).","PILME","Inclusion Criteria:\n\n* Breast cancer survivors diagnosed with GSM as a result of cancer treatment\n* Vaginal Health Index (VHI) score of ≤ 15.\n\nExclusion Criteria:\n\n* History of conservative treatment or surgery for pelvic floor dysfunction or GSM\n* Currently undergoing chemotherapy, or have undergone BC surgery but have not received chemotherapy or hormonal treatment.\n* Presence of concomitant or systemic diseases that could interfere with the proposed treatments, such as a recurrence of the oncological process, active or recurrent untreated urinary tract infections, hematuria, or cognitive impairments that hinder the participant's ability to comprehend study information, respond to questionnaires, provide informed consent, or fully participate in the study.","38 Years",{"count":202,"type":21},182,[24],"This randomized, single-blind clinical trial will compare the effectiveness of multimodal pelvic floor physiotherapy (PPT) and fractional CO2 vaginal laser therapy in reducing genitourinary syndrome of menopause (GSM) symptoms among breast cancer (BC) survivors. GSM, induced by cancer treatments, is common in BC survivors due to hormonal deprivation, and effective non-hormonal treatments are needed. The study will enroll 210 women diagnosed with GSM following BC treatment, who will be randomly assigned to either three sessions of CO2 vaginal laser therapy or eight sessions of multimodal PPT, which includes pelvic floor muscle training, vaginal non-ablative radiofrequency, education, and moisturizers. Primary outcomes will include perineal pain, sexual function, and health-related quality of life (HRQoL), with assessments at baseline, post-intervention, and at 3, 6, and 12 months. The hypothesis is that multimodal PPT will lead to greater improvements in pelvic pain, muscle function, and sexual health, with sustained benefits over time. This trial aims to provide evidence for non-invasive, non-hormonal treatments to manage GSM in BC survivors, filling a significant therapeutic gap.",[27,206],"Breast Cancer Female",[208,209,210,211,212,213,214,215],"Breas cancer","Cost-effectiveness","Dyspareunia","Genitourinary syndrome of menopause","Laser therapy","Menopause","Physiotherapy","Quality of life","2025-04-23",{"date":218,"type":45},"2025-04-27",{"date":220,"type":45},"2024-11-29",{"date":189,"type":21},{"name":223,"class":52},"University of Alcala",{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":22,"phases":234,"briefSummary":235,"conditions":236,"keywords":243,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":53},"100579772","treatment-of-vulvo-vaginal-atrophy-vva-using-vaginal-dilator-in-addition-to-usual-treatment-100579772","NCT06828640","Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment","Treatment of Vulvo-vaginal Atrophy (VVA) Using Vaginal Dilator in Addition to Usual Treatment : a Randomized Control Trial","Inclusion Criteria:\n\n* Peri- or postmenopausal women suffering from vulvovaginal atrophy (VVA)\n* Breast cancer survivors with VVA symptoms\n* Understand the study, be willing to participate, and sign an informed consent form.\n* The use of estrogen\u002Fprogestogen-based products (vaginal, oral, pellets, transdermal, etc.) is permitted but must be documented (this will be considered during randomization).\n\nExclusion Criteria:\n\n* Undiagnosed abnormal genital bleeding.\n* Administration of any investigational drug within 30 days prior to the screening visit.\n* Presence of a serious medical condition, neurological disorder, or significant comorbidities.\n* Other gynecological malignancies.\n* Recent vaginal surgery.\n* Clinically significant prolapse (POP-Q ≤ 2).\n* Current urinary tract or vaginal infection, or recent sexually transmitted infection.\n* Individuals with disabilities unable to communicate.\n* Women eligible for the study but unwilling to participate.","85 Years",{"count":233,"type":21},160,[24],"This is a randomized, controlled trial aiming to evaluate the effectiveness of adding vaginal dilators to the treatment of vulvovaginal atrophy.\n\nStudy Population:\n\nPeri- and postmenopausal women with VVA, including breast cancer survivors.\n\nDesign: Monocentric pilot RCT evaluating SoC (MHT, lubricants, moisturizers) (control group) to SoC + vaginal dilators (test group).\n\nVaginal Dilator : A silicone medical device will be used for gradual stretching progression. The kit includes dilators of progressively larger sizes.\n\nProcedures: Assessments at baseline, at 4 \\& 12 weeks\n\nMeasures : Vulvo Vaginal Atrophy severity , dyspareunia, Vaginal Health Index Score, Female Sexual Fonction Index, and Visual Analogue Scale (for vaginal dryness, vaginal and\u002For vulvar irritation\u002Fitching, and pain during sexual intercourse).\n\nStatistical Analysis:\n\nDifferences at baseline, 4 weeks, and 12 weeks will be tested using:\n\nTwo-sample t-test Mann-Whitney test\n\nStatistical Power:\n\nAssuming a 20% improvement in Group 1 and 40% in Group 2, with:\n\np \\\u003C 0.05 (type I error) 80% power (type II error), 160 patients needed across both groups.\n\nSoC = Standard of care RCT = Randimized control trial MHT = Menopausal hormonal therapy",[237,27,238,239,240,241,242],"Vulvo Vaginal Atrophy","Vaginal Atrophy in Breast Cancer Patients","Vaginal Atrophy Patients With GSM","Treatment","Sexual Disfunction","Dyspareunia (Female)",[244,245,211,246],"Vulvo vaginal atrophy","vaginal dilators","treatment","2025-02-11",{"date":249,"type":45},"2025-02-14",{"date":251,"type":45},"2024-10-16",{"date":253,"type":21},"2025-10",{"name":255,"class":52},"Centre Hospitalier Universitaire Saint Pierre"]