[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579772":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":60,"collaborators":18,"id":62,"slug":18,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":18,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":86,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Centre Hospitalier Universitaire Saint Pierre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Test Group : vaginal dilators","EXPERIMENTAL","A Test group receiving the standard treatment + a kit of vaginal dilators with progressively larger sizes.",[13],"Device: vaginal dilators",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group : placebo","NO_INTERVENTION","A control group receiving the standard treatment (which includes MHT, vaginal lubricants, and Moisturizers).",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","vaginal dilators","Evaluate the efficacy of vaginal dilators as an addition to Standard of Care in premenopausal or menopausal women, including breast cancer survivors",[9],[26],{"name":27,"affiliation":28,"role":29},"Serge Rozenberg, Gynaecologist","Saint Pierre University Hospital Center","STUDY_DIRECTOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Julie Piral, medical student","CONTACT","+33673428392","julie.piral@ulb.be",{"name":37,"role":33,"phone":38,"phoneExt":18,"email":39},"Aurélie Joris, gynaecologist","+32 2 535 34 86","aurelie.joris@stpierre-bru.be",[41],{"facility":28,"status":42,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Brussels","Brussels Capital","1000","Belgium",{"type":48,"coordinates":49},"Point",[50,51],4.34878,50.85045,{"lat":51,"lon":50},[54,55,58],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":56,"role":33,"phone":57,"phoneExt":18,"email":39},"Aurélie Joris, Gynaecologist","+32 2 535 3486",{"name":32,"role":59,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"type":61,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":72,"type":73},160,"ESTIMATED","INTERVENTIONAL",[76],"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",[79,80,81,82,83,84,85],"Vulvo Vaginal Atrophy","Genitourinary Syndrome of Menopause (GSM)","Vaginal Atrophy in Breast Cancer Patients","Vaginal Atrophy Patients With GSM","Treatment","Sexual Disfunction","Dyspareunia (Female)",[87,22,88,89],"Vulvo vaginal atrophy","Genitourinary syndrome of menopause","treatment","2025-02-11",{"date":92,"type":93},"2025-02-14","ACTUAL",{"date":95,"type":93},"2024-10-16",{"date":97,"type":73},"2025-10",{"name":5,"class":6},1]