{"id":"ev-dng-qlaira-bay86-5027","safety":{"commonSideEffects":[{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Breast tenderness"},{"rate":null,"effect":"Irregular bleeding/spotting"},{"rate":null,"effect":"Mood changes"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Estradiol valerate is a natural estrogen that is metabolized to estradiol, while dienogest is a progestin with antimineralocorticoid activity. Together, they suppress the luteinizing hormone (LH) surge and follicle-stimulating hormone (FSH), preventing ovulation and thickening cervical mucus to provide contraceptive efficacy. The combination is designed to provide consistent hormone levels with a more physiologic estrogen profile.","oneSentence":"EV/DNG is an estradiol valerate and dienogest combination oral contraceptive that prevents ovulation through hormonal suppression.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:46:32.997Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Contraception in women of reproductive age"},{"name":"Treatment of heavy menstrual bleeding in women desiring contraception"}]},"trialDetails":[{"nctId":"NCT00754065","phase":"PHASE3","title":"To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)","status":"COMPLETED","sponsor":"Bayer","startDate":"2008-09-08","conditions":"Contraception","enrollment":409},{"nctId":"NCT01602770","phase":"","title":"Qlaira Post-authorization Safety Study Related to Most Common Adverse Events in Mexican Women Who Wish to Avoid 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Contraceptive","status":"COMPLETED","sponsor":"Bayer","startDate":"2004-04","conditions":"Contraception","enrollment":1392}],"_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":[],"phase":"phase_3","status":"active","brandName":"EV/DNG (Qlaira, BAY86-5027)","genericName":"EV/DNG (Qlaira, BAY86-5027)","companyName":"Bayer","companyId":"bayer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"EV/DNG is an estradiol valerate and dienogest combination oral contraceptive that prevents ovulation through hormonal suppression. Used for Contraception in women of reproductive age, Treatment of heavy menstrual bleeding in women desiring contraception.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}