[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585285":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":26,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Centre Oscar Lambret","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Vaginal radiofrequency treatment","EXPERIMENTAL","The evaluator will be blinded to the intervention (different investigator for vaginal radiofrequency sessions and clinical evaluation consultationsup to 6 months, M0, M3 and M6).\n\nThe blinding will be lifted after the 6-month evaluation, with the possibility of radiofrequency treatment for patients in the control group who are not sufficiently relieved.",[13,14],"Device: GynWave-360","Other: Local hydratation",{"label":16,"type":17,"description":18,"interventionNames":19},"Reference treatment","ACTIVE_COMPARATOR","Local hydration: hyaluronic acid-based treatment, 3 applications per week Possibility of resorting to associated measures chosen by the investigator (physical therapy, vaginal dilators, etc.), excluding physical treatments (vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection, or lipomodelling).",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","GynWave-360","For patients randomized to the experimental group:\n\n3 sessions of 20 minutes each, spaced 4 to 6 weeks apart (M0, M1, M2) ideally, with +\u002F- 1 maintenance session between 8 and 12 months after the first session (M8-12).",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Local hydratation","Reference treatment combining local hydration (hyaluronic acid-based treatment, 3 times a week), with the possibility of using associated measures at the investigator's discretion (physiotherapy, vaginal dilators, etc.).",[16,9],[32],{"name":33,"affiliation":5,"role":34},"Julie DEMETZ, MD","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Fanny BEN OUNE","CONTACT","+33320295896","promotion@o-lambret.fr",[42],{"facility":5,"status":43,"city":44,"state":26,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Lille","59020","France","FR",{"type":49,"coordinates":50},"Point",[51,52],3.05512,50.63391,{"lat":52,"lon":51},[55],{"name":56,"role":38,"phone":57,"phoneExt":26,"email":58},"Julie JD DEMETZ, MD","+33320295935","j-demetz@o-lambret.fr",{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[62],{"name":63,"class":64},"MATMATECH","UNKNOWN","100585285","efficacy-and-safety-of-vaginal-radiofrequency-for-vulvovaginal-atrophy-in-breast-cancer-patients-100585285",false,"NCT06900374","Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients","RF-Vaginale : Randomised Phase III Trial Evaluating the Efficacy and Safety of Vaginal Radiofrequency in the Management of Vulvovaginal Atrophy and Dryness in Patients Treated for Breast Cancer","RF-Vaginale","INCLUSION CRITERIA :\n\n* Patient over 40 years\n* Presenting disabling vaginal dryness symptoms despite well-administered local moisturizing treatment, attested by a vaginal dryness score ≥3\n* Patient undergoing adjuvant treatment for breast cancer\n* Patient treated with aromatase inhibitors +\u002F- LHRH agonist for at least 3 months with a planned remaining duration of at least 12 months\n* Patient affiliated to a social security organization\n* Patient having signed the informed consent for the present study\n\nEXCLUSION CRITERIA:\n\n* Contraindications related to the radiofrequency technique:\n\n  * Ongoing urinary tract infection\n  * Pacemaker\n  * IUD intrauterine device\n  * Pregnancy\n* Mucocutaneous disease with vulvovaginal localization: infection, sore, scleratrophic lichen, psoriasis, eczema, etc.\n* Neurodegenerative disease with perineal involvement\n* Current or recent treatment (within the last 12 months) with other physical methods: vaginal laser, photobiomodulation, PRP injection, hyaluronic acid injection or lipo-modeling.\n* Pregnant or breast-feeding women\n* Patients under guardianship or trusteeship.","FEMALE","40 Years",{"count":76,"type":77},75,"ESTIMATED","INTERVENTIONAL",[80],"NA","This Phase III, randomized, balanced, parallel-group, multicenter trial aims to evaluate the effect of vaginal radiofrequency on symptoms of vaginal dryness at six months. The study compares vaginal radiofrequency treatment with non-hormonal hydration therapy in a population of patients undergoing adjuvant hormonal therapy with aromatase inhibitors, with or without LHRH agonists, for breast cancer.\n\nPatients will be randomly assigned to one of two parallel treatment groups until the six-month assessment:\n\nThe first group will receive the reference treatment, which consists of local hydration using a hyaluronic acid-based treatment applied three times a week. Additionally, investigators may incorporate supportive measures at their discretion, such as physiotherapy or vaginal dilators.\n\nThe second group will receive the same reference treatment combined with vaginal radiofrequency therapy. This intervention consists of three sessions, each spaced 4 to 6 weeks apart.",[83,84,85],"Vaginal Dryness","Breast Cancer","Vulvovaginal Atrophy",[87,88,89,90],"Vaginal dryness","vaginal atrophy","vaginal radiofrequency","breast cancer","2026-03-16",{"date":93,"type":94},"2026-03-18","ACTUAL",{"date":96,"type":94},"2025-06-12",{"date":98,"type":77},"2028-06",{"name":5,"class":6},1]