[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612995":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":26,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":26,"enrollmentInfo":70,"targetDuration":26,"studyType":73,"phases":74,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":86,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"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",[38,55],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Cincinnati Urogynecology Associates","Cincinnati","Ohio","45220","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-84.51439,39.12711,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":35,"phoneExt":26,"email":54},"Jennifer Hodge, RN","Jennifer_hodge2@trihealth.com",{"facility":56,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":57,"geoPoint":59,"contacts":26},"TriHealth",{"type":46,"coordinates":58},[48,49],{"lat":49,"lon":48},{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100612995","phase-2-use-of-topical-testosterone-and-estrogen-vs-estrogen-alone-in-vulvodynia-a-randomized-controlled-trial-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":71,"type":72},44,"ESTIMATED","INTERVENTIONAL",[75,76],"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.",[79,80,81],"Vulvodynia","Dyspareunia","Lichen Sclerosus of Vulva",[83,84,85],"topical testosterone","estrogen cream","vulvodynia","NOT_YET_RECRUITING","2025-11-21",{"date":89,"type":90},"2025-12-03","ACTUAL",{"date":92,"type":72},"2025-12",{"date":94,"type":72},"2026-08",{"name":5,"class":6},2]