{"id":"dhea-0-5","safety":{"commonSideEffects":[{"rate":null,"effect":"Vaginal discharge"},{"rate":null,"effect":"Vaginal irritation"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Breast tenderness"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"DHEA is an endogenous steroid hormone precursor that declines with age. When administered as a 0.5% vaginal cream formulation (Prasterone), it is locally converted to active androgens and estrogens by tissue enzymes, providing hormone replacement therapy specifically for vaginal atrophy and related menopausal symptoms without systemic hormone exposure.","oneSentence":"DHEA (dehydroepiandrosterone) is a prohormone that is converted to testosterone and estrogen in peripheral tissues, restoring hormone levels in postmenopausal women.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:09:25.133Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Moderate to severe dyspareunia due to menopause-related vaginal atrophy"},{"name":"Vaginal atrophy and related menopausal symptoms"}]},"trialDetails":[{"nctId":"NCT03383133","phase":"EARLY_PHASE1","title":"Studies of Sulfur Metabolism in Humans","status":"COMPLETED","sponsor":"Albert Einstein College of Medicine","startDate":"2018-01-11","conditions":"Metabolic Side Effects of Drugs","enrollment":1},{"nctId":"NCT01724242","phase":"PHASE2, PHASE3","title":"Vaginal DHEA for Women After Breast Cancer","status":"WITHDRAWN","sponsor":"Hadassah Medical Organization","startDate":"2013-02","conditions":"Vaginal Dryness, Breast Cancer, Urinary Incontinence","enrollment":""},{"nctId":"NCT01256671","phase":"PHASE3","title":"DHEA Against Vaginal Atrophy - Safety Study of 12 Months","status":"COMPLETED","sponsor":"EndoCeutics Inc.","startDate":"2010-12","conditions":"Vaginal Atrophy","enrollment":530},{"nctId":"NCT01846442","phase":"PHASE3","title":"Topical DHEA Against Vaginal Atrophy","status":"COMPLETED","sponsor":"EndoCeutics Inc.","startDate":"2007-06","conditions":"Vaginal Atrophy","enrollment":218},{"nctId":"NCT01256684","phase":"PHASE3","title":"DHEA Against Vaginal Atrophy - 3-Month Efficacy Study","status":"COMPLETED","sponsor":"EndoCeutics Inc.","startDate":"2010-12","conditions":"Vaginal Atrophy","enrollment":255},{"nctId":"NCT01358760","phase":"PHASE3","title":"Dehydroepiandrosterone (DHEA) Against Vaginal Atrophy","status":"COMPLETED","sponsor":"EndoCeutics Inc.","startDate":"2011-06","conditions":"Vaginal Atrophy","enrollment":450}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":486,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Prasterone, Dehydroepiandrosterone"],"phase":"phase_3","status":"active","brandName":"DHEA (0.5%)","genericName":"DHEA (0.5%)","companyName":"EndoCeutics Inc.","companyId":"endoceutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"DHEA (dehydroepiandrosterone) is a prohormone that is converted to testosterone and estrogen in peripheral tissues, restoring hormone levels in postmenopausal women. Used for Moderate to severe dyspareunia due to menopause-related vaginal atrophy, Vaginal atrophy and related menopausal symptoms.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}