{"id":"norethisterone-enantate","safety":{"commonSideEffects":[{"rate":null,"effect":"Menstrual irregularities (amenorrhea, breakthrough bleeding)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Breast tenderness"},{"rate":null,"effect":"Weight changes"},{"rate":null,"effect":"Mood changes"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"As a long-acting progestin ester, norethisterone enantate works primarily by inhibiting the luteinizing hormone (LH) surge needed for ovulation. It also thickens cervical mucus to impede sperm penetration and alters the uterine lining to prevent implantation. The enantate ester formulation provides sustained release, allowing for extended contraceptive coverage with infrequent dosing.","oneSentence":"Norethisterone enantate is a synthetic progestin that suppresses ovulation and alters the endometrium and cervical mucus to prevent pregnancy.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-27T23:57:41.788Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Contraception (long-acting injectable)"}]},"trialDetails":[{"nctId":"NCT03901131","phase":"","title":"PROMES: A Clinical Study in Which Researchers Want to Learn More About the Safety Profile of MESIGYNA (Norethisterone Enantate 50 mg and Estradiol Valerate 5 mg) Used as a Medication to Prevent Pregnancy for Adult Women in Reproductive Age in the Peruvian Population at the Outpatient Clinic.","status":"COMPLETED","sponsor":"Bayer","startDate":"2019-08-26","conditions":"Contraceptive","enrollment":296},{"nctId":"NCT05362019","phase":"NA","title":"Effects of One-to-one Service on the Continuation and Satisfaction of Contraceptive Use.","status":"UNKNOWN","sponsor":"National Research Institute for Family Planning, China","startDate":"2022-05","conditions":"Contraception Behavior, Contraceptive Usage","enrollment":400},{"nctId":"NCT02038335","phase":"","title":"HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC","status":"COMPLETED","sponsor":"University of Pittsburgh","startDate":"2014-02","conditions":"Contraception, HIV, Immune Cells (Mucosal and Systemic)","enrollment":451},{"nctId":"NCT02905890","phase":"PHASE4","title":"The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis","status":"COMPLETED","sponsor":"London School of Hygiene and Tropical Medicine","startDate":"2017-10-02","conditions":"Bacterial Vaginosis, HIV","enrollment":250},{"nctId":"NCT02404038","phase":"NA","title":"A Study to Evaluate the Acceptability and Preference for Contraceptive Options as Proxy for HIV Prevention Methods","status":"UNKNOWN","sponsor":"Desmond Tutu HIV Centre","startDate":"2015-07","conditions":"HIV","enrollment":131},{"nctId":"NCT02170038","phase":"PHASE1","title":"Clinical Study Investigating the Conversion of the Contraceptive Compound Norethisterone Within the Body Towards the Contraceptive Compound Ethinylestradiol","status":"COMPLETED","sponsor":"Bayer","startDate":"2014-06","conditions":"Pharmacokinetics","enrollment":16}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":18,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Noristerat"],"phase":"marketed","status":"active","brandName":"Norethisterone enantate","genericName":"Norethisterone enantate","companyName":"London School of Hygiene and Tropical Medicine","companyId":"london-school-of-hygiene-and-tropical-medicine","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Norethisterone enantate is a small molecule used as a form of hormonal birth control to prevent pregnancy in women. It is administered via injection and may be used following childbirth, miscarriage, or abortion.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}