[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulvo-vaginal-atrophy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulvo-vaginal-atrophy":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100579772","treatment-of-vulvo-vaginal-atrophy-vva-using-vaginal-dilator-in-addition-to-usual-treatment-100579772",false,"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.","FEMALE","18 Years","85 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"NA","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",[27,28,29,30,31,32,33],"Vulvo Vaginal Atrophy","Genitourinary Syndrome of Menopause (GSM)","Vaginal Atrophy in Breast Cancer Patients","Vaginal Atrophy Patients With GSM","Treatment","Sexual Disfunction","Dyspareunia (Female)",[35,36,37,38],"Vulvo vaginal atrophy","vaginal dilators","Genitourinary syndrome of menopause","treatment","RECRUITING","2025-02-11",{"date":42,"type":43},"2025-02-14","ACTUAL",{"date":45,"type":43},"2024-10-16",{"date":47,"type":21},"2025-10",{"name":49,"class":50},"Centre Hospitalier Universitaire Saint Pierre","OTHER"]