{"id":"black-cohosh-icr-or-tibolone","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Gastrointestinal upset"},{"rate":null,"effect":"Vaginal bleeding or spotting"},{"rate":null,"effect":"Breast tenderness"},{"rate":null,"effect":"Dizziness"}]},"_chembl":{"chemblId":"CHEMBL2103774","moleculeType":"Small molecule","molecularWeight":"312.45"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Black Cohosh is a phytoestrogen-containing herbal extract that may reduce hot flashes and night sweats through serotonergic mechanisms and possible weak estrogen receptor modulation. Tibolone is a synthetic steroid that selectively activates estrogen, progesterone, and androgen receptors in a tissue-specific manner, providing menopausal symptom relief while potentially minimizing systemic hormonal exposure. The combination or comparison in this Phase 3 trial likely evaluates efficacy and safety profiles for menopausal symptom management.","oneSentence":"Black Cohosh (iCR) and tibolone work through different pathways—Black Cohosh may modulate serotonin and other neurotransmitters to reduce vasomotor symptoms, while tibolone acts as a selective tissue estrogenic activity regulator (STEAR) with mixed estrogenic, progestagenic, and androgenic effects.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:04:28.884Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Vasomotor symptoms (hot flashes, night sweats) associated with menopause"},{"name":"Menopausal syndrome"}]},"trialDetails":[{"nctId":"NCT00299364","phase":"PHASE3","title":"Comparison of the Efficacy and Tolerability of Black Cohosh Vs Tibolone in Patients With Menopausal Symptoms","status":"COMPLETED","sponsor":"Schaper & Bruemmer GmbH & Co KG","startDate":"2004-09","conditions":"Menopause","enrollment":240}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1172,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Black Cohosh (iCR) or tibolone","genericName":"Black Cohosh (iCR) or tibolone","companyName":"Schaper & Bruemmer GmbH & Co KG","companyId":"schaper-bruemmer-gmbh-co-kg","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Black Cohosh (iCR) and tibolone work through different pathways—Black Cohosh may modulate serotonin and other neurotransmitters to reduce vasomotor symptoms, while tibolone acts as a selective tissue estrogenic activity regulator (STEAR) with mixed estrogenic, progestagenic, and androgenic effects. Used for Vasomotor symptoms (hot flashes, night sweats) associated with menopause, Menopausal syndrome.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}