{"id":"ortho-tri-cyclen-lo","safety":{"commonSideEffects":[{"rate":"10-15","effect":"Nausea"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Breast tenderness"},{"rate":"5-10","effect":"Breakthrough bleeding"},{"rate":"2-5","effect":"Mood changes"},{"rate":"0.3-0.4","effect":"Venous thromboembolism"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The drug combines a progestin (norgestimate) and an estrogen (ethinyl estradiol) to inhibit the luteinizing hormone (LH) surge required for ovulation. It also thickens cervical mucus to impede sperm penetration and alters the endometrium to prevent implantation. The 'LO' designation indicates a lower-dose formulation of ethinyl estradiol compared to standard Ortho Tri-Cyclen.","oneSentence":"Ortho Tri-Cyclen LO is an oral contraceptive that prevents pregnancy by suppressing ovulation through a combination of norgestimate and ethinyl estradiol.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:59:10.518Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Contraception (pregnancy prevention)"},{"name":"Acne vulgaris (FDA-approved indication)"}]},"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":"NCT00635570","phase":"PHASE4","title":"Acceptability of the NuvaRing Among Students","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2008-07","conditions":"Birth Control Compliance","enrollment":273},{"nctId":"NCT02533427","phase":"PHASE1","title":"Study to Evaluate Effect of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination on the Pharmacokinetics of a Representative Hormonal Contraceptive Medication, Norgestimate/Ethinyl Estradiol","status":"COMPLETED","sponsor":"Gilead Sciences","startDate":"2015-10-29","conditions":"HCV Infection","enrollment":15},{"nctId":"NCT00745901","phase":"PHASE4","title":"Study to Evaluate Cycle Control With Norgestimate/Ethinyl Estradiol and Drospirenone/Ethinyl Estradiol in Healthy Sexually Active Females","status":"COMPLETED","sponsor":"Ortho-McNeil Janssen Scientific Affairs, LLC","startDate":"2008-05","conditions":"Contraception","enrollment":355},{"nctId":"NCT00709644","phase":"PHASE1","title":"Bioequivalence Study of the Oral Contraceptive (OC) Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2005-04","conditions":"Pharmacokinetics, Therapeutic Equivalency, Contraceptives, Oral","enrollment":54},{"nctId":"NCT00399685","phase":"PHASE1","title":"Drug Interaction - Oral Contraceptive","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2006-12","conditions":"HIV Infections","enrollment":28},{"nctId":"NCT00357604","phase":"PHASE1","title":"Atazanavir and Ritonavir (ATV/RTV) and an Oral Contraceptive in Healthy Females","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2006-07","conditions":"HIV Infections","enrollment":22},{"nctId":"NCT00344383","phase":"PHASE2","title":"An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen","status":"COMPLETED","sponsor":"McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.","startDate":"2003-11","conditions":"Metrorrhagia","enrollment":61}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":5,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Ortho Tri-Cyclen LO","genericName":"Ortho Tri-Cyclen LO","companyName":"Bristol-Myers Squibb","companyId":"bristol-myers-squibb","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ortho Tri-Cyclen LO is an oral contraceptive that prevents pregnancy by suppressing ovulation through a combination of norgestimate and ethinyl estradiol. Used for Contraception (pregnancy prevention), Acne vulgaris (FDA-approved indication).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}