{"id":"drospirenone-ethinylestradiol-methyltetrahydrofolate","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Breast tenderness"},{"rate":null,"effect":"Breakthrough bleeding"},{"rate":"3-4 per 10,000 woman-years","effect":"Venous thromboembolism"}]},"_chembl":{"chemblId":"CHEMBL3186202","moleculeType":"Small molecule","molecularWeight":"366.50"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Drospirenone is a fourth-generation progestin with antimineralocorticoid activity that inhibits the LH surge necessary for ovulation, while ethinylestradiol is a synthetic estrogen that suppresses FSH and stabilizes the endometrium. The addition of methyltetrahydrofolate (the active form of folic acid) provides periconceptional folate supplementation to reduce the risk of neural tube defects in case of contraceptive failure or planned pregnancy.","oneSentence":"This combination oral contraceptive prevents pregnancy by suppressing ovulation through progestin and estrogen activity, while methyltetrahydrofolate supplementation reduces neural tube defect risk.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:09:57.123Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Contraception with reduced risk of neural tube defects"}]},"trialDetails":[{"nctId":"NCT00468481","phase":"PHASE3","title":"Efficacy and Safety Study for an Oral Contraceptive Containing Folate","status":"COMPLETED","sponsor":"Bayer","startDate":"2007-04","conditions":"Neural Tube Defects, Contraception, Oral Contraceptives (OC)","enrollment":385},{"nctId":"NCT01258660","phase":"PHASE1","title":"Assessment of the Pharmacodynamic Effect on Plasma Folate and Red Blood Cell Folate and Comparison of the Folate Metabolites During the 24 Weeks of Treatment (Yasmin + Metafolin Versus Yasmin + Folic Acid) Followed by a 20 Week Elimination Phase of Folate","status":"COMPLETED","sponsor":"Bayer","startDate":"2006-12","conditions":"Contraception","enrollment":172},{"nctId":"NCT01253174","phase":"PHASE1","title":"Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: Yasmin and Yasmin + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and Yasmin + Levomefolate Calcium (Metafolin)","status":"COMPLETED","sponsor":"Bayer","startDate":"2006-08","conditions":"Contraception","enrollment":48},{"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":[],"phase":"phase_3","status":"active","brandName":"Drospirenone/Ethinylestradiol/Methyltetrahydrofolate","genericName":"Drospirenone/Ethinylestradiol/Methyltetrahydrofolate","companyName":"Bayer","companyId":"bayer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This combination oral contraceptive prevents pregnancy by suppressing ovulation through progestin and estrogen activity, while methyltetrahydrofolate supplementation reduces neural tube defect risk. Used for Contraception with reduced risk of neural tube defects.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}