{"id":"ee20-drsp-yaz-bay86-5300","safety":{"commonSideEffects":[{"rate":"10-15","effect":"Nausea"},{"rate":"10-15","effect":"Headache"},{"rate":"5-10","effect":"Breast tenderness"},{"rate":"5-10","effect":"Breakthrough bleeding"},{"rate":"5","effect":"Mood changes"},{"rate":"0.3-0.4","effect":"Venous thromboembolism"}]},"_chembl":{"chemblId":"CHEMBL601786","moleculeType":"Small molecule","molecularWeight":"389.36"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ethinyl estradiol (EE) is a synthetic estrogen that suppresses the luteinizing hormone (LH) surge needed for ovulation. Drospirenone (DRSP) is a progestin with antimineralocorticoid activity that further inhibits ovulation and alters the endometrium and cervical mucus to prevent sperm penetration. The combination provides contraceptive efficacy through multiple mechanisms.","oneSentence":"EE20/DRSP is an oral contraceptive combining ethinyl estradiol and drospirenone to prevent ovulation and thicken cervical mucus.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:35:50.159Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Contraception"},{"name":"Acne vulgaris (moderate)"},{"name":"Premenstrual dysphoric disorder (PMDD)"}]},"trialDetails":[{"nctId":"NCT02710708","phase":"PHASE4","title":"YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China","status":"COMPLETED","sponsor":"Bayer","startDate":"2016-05-27","conditions":"Contraception","enrollment":1921},{"nctId":"NCT01375998","phase":"","title":"YAZ Post-marketing Surveillance in Japan","status":"COMPLETED","sponsor":"Bayer","startDate":"2011-06-09","conditions":"Dysmenorrhea","enrollment":3273},{"nctId":"NCT01697111","phase":"PHASE3","title":"Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis","status":"COMPLETED","sponsor":"Bayer","startDate":"2012-10","conditions":"Endometriosis","enrollment":312},{"nctId":"NCT02617537","phase":"PHASE3","title":"To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea","status":"WITHDRAWN","sponsor":"Bayer","startDate":"2016-01","conditions":"Dysmenorrhea","enrollment":""},{"nctId":"NCT01892904","phase":"PHASE3","title":"Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea","status":"COMPLETED","sponsor":"Bayer","startDate":"2013-07","conditions":"Dysmenorrhea","enrollment":216},{"nctId":"NCT00818519","phase":"PHASE3","title":"GA YAZ ACNE in China Phase III","status":"COMPLETED","sponsor":"Bayer","startDate":"2008-12","conditions":"Acne Vulgaris","enrollment":179},{"nctId":"NCT00998257","phase":"","title":"Regulatory Post Marketing Surveillance Study on YAZ","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-07","conditions":"Contraception, Premenstrual Syndrome, Acne","enrollment":770},{"nctId":"NCT00266032","phase":"PHASE3","title":"Study on Safety and Efficacy of an Oral Contraceptive in Long Cycles","status":"COMPLETED","sponsor":"Bayer","startDate":"2005-12","conditions":"Contraception","enrollment":1166},{"nctId":"NCT01076582","phase":"PHASE3","title":"Comparative Trial in Hormone Withdrawal Associated Symptoms","status":"COMPLETED","sponsor":"Bayer","startDate":"2010-04","conditions":"Oral Contraceptive","enrollment":592},{"nctId":"NCT00824187","phase":"PHASE3","title":"YAZ Premenstrual Dysphoric Disorder (PMDD) in China","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-01","conditions":"Premenstrual Dysphoric Disorder ( PMDD)","enrollment":187},{"nctId":"NCT00567164","phase":"PHASE3","title":"Efficacy and Safety of Two Flexible Extended Regimens of BAY86-5300 (SH T00186D) in Comparison With the Conventional Regimen of YAZ","status":"COMPLETED","sponsor":"Bayer","startDate":"2007-10","conditions":"Contraception, Ovulation Inhibition, Contraceptives, Oral","enrollment":1887},{"nctId":"NCT01253187","phase":"PHASE1","title":"Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: YAZ and YAZ + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and YAZ + Levomefolate Calcium (Metafolin)","status":"COMPLETED","sponsor":"Bayer","startDate":"2006-10","conditions":"Contraception","enrollment":44}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["SH T00186D"],"phase":"marketed","status":"active","brandName":"EE20/DRSP (YAZ, BAY86-5300)","genericName":"EE20/DRSP (YAZ, BAY86-5300)","companyName":"Bayer","companyId":"bayer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"EE20/DRSP is an oral contraceptive combining ethinyl estradiol and drospirenone to prevent ovulation and thicken cervical mucus. Used for Contraception, Acne vulgaris (moderate), Premenstrual dysphoric disorder (PMDD).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}