{"id":"ethinyl-estradiol-levonorgestrel-folic-acid","safety":{"commonSideEffects":[{"rate":"10-15","effect":"Nausea"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Breast tenderness"},{"rate":"5-15","effect":"Breakthrough bleeding"},{"rate":"5","effect":"Mood changes"},{"rate":"0.3-0.4","effect":"Venous thromboembolism"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Ethinyl estradiol and levonorgestrel work synergistically to inhibit the luteinizing hormone (LH) surge and suppress follicle-stimulating hormone (FSH), preventing ovulation and thickening cervical mucus to provide contraceptive efficacy. The addition of folic acid addresses the known depletion of folate caused by hormonal contraceptives, reducing the risk of neural tube defects if unintended pregnancy occurs or upon discontinuation.","oneSentence":"This combination oral contraceptive suppresses ovulation through progestin and estrogen activity while folic acid supplementation reduces neural tube defect risk in pregnancy.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:46:30.038Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Contraception and prevention of neural tube defects"}]},"trialDetails":[{"nctId":"NCT03359057","phase":"PHASE3","title":"Trial Evaluating Folic Acid Supplementation by Concomitant Administration of Ethinyl Estradiol + Levonorgestrel","status":"COMPLETED","sponsor":"Galeno Desenvolvimento de Pesquisas Clínicas","startDate":"2013-02-26","conditions":"Contraception","enrollment":36}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"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":"ethinyl estradiol + levonorgestrel + folic acid","genericName":"ethinyl estradiol + levonorgestrel + folic acid","companyName":"Galeno Desenvolvimento de Pesquisas Clínicas","companyId":"galeno-desenvolvimento-de-pesquisas-cl-nicas","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination oral contraceptive suppresses ovulation through progestin and estrogen activity while folic acid supplementation reduces neural tube defect risk in pregnancy. Used for Contraception and prevention of neural tube defects.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}