{"id":"add-back-therapy-1-tibolone","safety":{"commonSideEffects":[{"rate":"10-20","effect":"Vaginal bleeding or spotting"},{"rate":"5-10","effect":"Breast tenderness"},{"rate":"5-10","effect":"Headache"},{"rate":"3-8","effect":"Nausea"},{"rate":"5-10","effect":"Weight gain"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Tibolone is a prodrug that is metabolized in the body to three active metabolites with different tissue-selective activities. It binds to estrogen, progesterone, and androgen receptors with varying affinities depending on the tissue, providing symptom relief in menopause while minimizing some adverse effects associated with conventional hormone replacement therapy. This selective activity profile makes it particularly useful for managing vasomotor symptoms and bone loss in postmenopausal women.","oneSentence":"Tibolone is a synthetic steroid that acts as a selective tissue estrogenic activity regulator (STEAR), providing estrogenic, progestagenic, and androgenic effects to alleviate menopausal symptoms.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:18:38.764Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Menopausal vasomotor symptoms (hot flushes, night sweats)"},{"name":"Postmenopausal bone loss prevention"},{"name":"Postmenopausal vaginal atrophy"}]},"trialDetails":[{"nctId":"NCT05568940","phase":"","title":"Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids","status":"WITHDRAWN","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","startDate":"2024-09","conditions":"Endometriosis, Fibroids","enrollment":""},{"nctId":"NCT02393482","phase":"PHASE4","title":"Psychological Impact of Amenorrhea in Women With Endometriosis","status":"UNKNOWN","sponsor":"University of Cagliari","startDate":"2021-06","conditions":"Amenorrhea, Endometriosis, Quality of Life","enrollment":50},{"nctId":"NCT00654524","phase":"PHASE4","title":"Randomized Study of Gonadotropin-releasing-hormone Agonist (GnRH-a) or Expectant Management for Endometriosis","status":"UNKNOWN","sponsor":"Zhejiang University","startDate":"2008-03","conditions":"Endometriosis","enrollment":60}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":14,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Add back therapy 1 (tibolone)","genericName":"Add back therapy 1 (tibolone)","companyName":"University of Cagliari","companyId":"university-of-cagliari","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Tibolone is a synthetic steroid that acts as a selective tissue estrogenic activity regulator (STEAR), providing estrogenic, progestagenic, and androgenic effects to alleviate menopausal symptoms. Used for Menopausal vasomotor symptoms (hot flushes, night sweats), Postmenopausal bone loss prevention, Postmenopausal vaginal atrophy.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}