[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612995":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":59,"collaborators":26,"id":61,"slug":26,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":26,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":26,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":80,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"TriHealth Inc.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of care","ACTIVE_COMPARATOR","Patients receiving standard of care",[13],"Drug: Estradiol 0.01% Vag Cream",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment","EXPERIMENTAL","Patients receiving study treatment",[19],"Drug: testosterone 0.1% and estradiol 0.01% vaginal cream",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Estradiol 0.01% Vag Cream","0.01% Estradiol cream, 1g to be applied to the vestibule twice daily for 12 weeks",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"testosterone 0.1% and estradiol 0.01% vaginal cream","0.01% Estradiol and 0.1% testosterone cream, apply 1g to the vestibule twice daily for 12 weeks",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Gisele Moran, MD, MPH","CONTACT","513-463-4300","gisele_moran@trihealth.com",[38,54],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Cincinnati Urogynecology Associates","Cincinnati","Ohio","45220","United States",{"type":45,"coordinates":46},"Point",[47,48],-84.51439,39.12711,{"lat":48,"lon":47},[51],{"name":52,"role":34,"phone":35,"phoneExt":26,"email":53},"Jennifer Hodge, RN","Jennifer_hodge2@trihealth.com",{"facility":55,"status":26,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":56,"geoPoint":58,"contacts":26},"TriHealth",{"type":45,"coordinates":57},[47,48],{"lat":48,"lon":47},{"type":60,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100612995",false,"NCT07260825","Use of Topical Testosterone and Estrogen vs Estrogen Alone in Vulvodynia: a Randomized Controlled Trial","Inclusion Criteria:\n\n* 18 years or older\n* Patients with vulvodynia who present with pain (with vaginal penetration) rating score of 4 or greater\n\nExclusion Criteria:\n\n* Active vaginal infection\n* Pregnancy\n* Breast-feeding\n* Taking anti-androgenic medication (finasteride, dutasteride)\n* Using any other topical hormones to the vulva or vagina","FEMALE","18 Years",{"count":69,"type":70},44,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE2","PHASE3","We are looking to see if patients using both topical testosterone and estrogen will have a greater improvement in pain with vaginal penetration compared to those using topical estrogen alone.",[77,78,79],"Vulvodynia","Dyspareunia","Lichen Sclerosus of Vulva",[81,82,83],"topical testosterone","estrogen cream","vulvodynia","NOT_YET_RECRUITING","2025-11-21",{"date":87,"type":88},"2025-12-03","ACTUAL",{"date":90,"type":70},"2025-12",{"date":92,"type":70},"2026-08",{"name":5,"class":6},2]