{"id":"ortho-tri-cyclen","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":{"chemblId":"CHEMBL501773","moleculeType":"Small molecule","molecularWeight":"229.75"},"_dailymed":{"setId":"c7de193c-d730-4f63-aa23-178b5f400967","title":"ORTHO TRI CYCLEN (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.]"},"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. Additionally, it thickens cervical mucus to impede sperm penetration and alters the endometrium to prevent implantation. The triphasic formulation varies hormone doses across the cycle to mimic natural hormonal patterns while maintaining contraceptive efficacy.","oneSentence":"Ortho Tri-Cyclen is an oral contraceptive that prevents pregnancy by suppressing ovulation through a combination of norgestimate and ethinyl estradiol.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:59:01.742Z","_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":"NCT04039204","phase":"PHASE2","title":"Elagolix for Fertility Enhancement Clinical Trial","status":"COMPLETED","sponsor":"Wake Forest University Health Sciences","startDate":"2022-01-15","conditions":"Endometriosis, Unexplained Infertility","enrollment":10},{"nctId":"NCT04423068","phase":"EARLY_PHASE1","title":"Inpatient Adolescent Contraception","status":"COMPLETED","sponsor":"Children's Mercy Hospital Kansas City","startDate":"2020-12-10","conditions":"Pregnancy Related, Contraception, Contraceptive Usage","enrollment":25},{"nctId":"NCT04718636","phase":"PHASE1","title":"A Study to Evaluate Effects of CC-99677 on the Pharmacokinetics of an Oral Contraceptive in Healthy Female Participants","status":"COMPLETED","sponsor":"Celgene","startDate":"2020-09-30","conditions":"Healthy Volunteers","enrollment":28},{"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":"NCT02080468","phase":"PHASE1","title":"Evaluate the Effect of Ethinyl Estradiol/Norgestimate on the Pharmacokinetics of Lomitapide in Healthy Female Subjects","status":"COMPLETED","sponsor":"Aegerion Pharmaceuticals, Inc.","startDate":"2014-02-19","conditions":"Healthy","enrollment":32},{"nctId":"NCT02792517","phase":"PHASE1","title":"Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females","status":"COMPLETED","sponsor":"Amgen","startDate":"2016-02-12","conditions":"Headache, Migraine","enrollment":41},{"nctId":"NCT01373931","phase":"PHASE1","title":"A Study of LY2216684 in Healthy Females","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2011-06","conditions":"Depressive Disorder, Major","enrollment":20},{"nctId":"NCT01746732","phase":"PHASE1","title":"A Study of Evacetrapib in Healthy Female Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2012-12","conditions":"Healthy Volunteers","enrollment":23},{"nctId":"NCT01475513","phase":"PHASE4","title":"Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women","status":"COMPLETED","sponsor":"Virginia Commonwealth University","startDate":"2011-11","conditions":"Insulin Sensitivity, Cardiovascular Risk, Perimenopausal Disorder","enrollment":47},{"nctId":"NCT00205504","phase":"PHASE4","title":"Oral Contraceptives in the Metabolic Syndrome","status":"COMPLETED","sponsor":"Virginia Commonwealth University","startDate":"2005-06","conditions":"Metabolic Syndrome X, Insulin Resistance, Obesity","enrollment":46},{"nctId":"NCT02157467","phase":"PHASE1","title":"Study of Combined Oral Contraceptive Effects in Female Subjects","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2014-06-02","conditions":"Infection, Human Immunodeficiency Virus","enrollment":46},{"nctId":"NCT01243580","phase":"PHASE1","title":"AG200-15 Transdermal Contraceptive Delivery System (TCDS) of Levonorgestrel and Ethinyl Estradiol","status":"COMPLETED","sponsor":"Agile Therapeutics","startDate":"2009-08","conditions":"Healthy","enrollment":36},{"nctId":"NCT02213029","phase":"PHASE1","title":"A Study to Evaluate Pharmacokinetics, Pharmacodynamics and Tissue Concentrations of Epelsiban","status":"TERMINATED","sponsor":"GlaxoSmithKline","startDate":"2014-08-28","conditions":"Embryo Transfer","enrollment":33},{"nctId":"NCT00775190","phase":"NA","title":"Side Effect Profiles of Brand Name Versus Generic Oral Contraceptives","status":"TERMINATED","sponsor":"Corewell Health East","startDate":"2008-10","conditions":"Contraception","enrollment":12},{"nctId":"NCT02494609","phase":"PHASE1","title":"Oral Contraceptive DDI Study","status":"UNKNOWN","sponsor":"Lexicon Pharmaceuticals","startDate":"2015-07","conditions":"Healthy","enrollment":30},{"nctId":"NCT02144246","phase":"PHASE1","title":"Contraceptive Hormones and Women With Cystic Fibrosis","status":"TERMINATED","sponsor":"University of Pennsylvania","startDate":"2014-05","conditions":"Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception","enrollment":5},{"nctId":"NCT00983957","phase":"PHASE1","title":"Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2009-10","conditions":"Chronic Hepatitis C","enrollment":47},{"nctId":"NCT01458210","phase":"PHASE1","title":"A Study of the Effect of Dulaglutide on How the Body Handles Oral Contraceptive in Healthy Female Participants","status":"COMPLETED","sponsor":"Eli Lilly and Company","startDate":"2011-10","conditions":"Diabetes Mellitus, Type 2","enrollment":22},{"nctId":"NCT02127593","phase":"PHASE1","title":"A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2013-06","conditions":"Healthy","enrollment":101},{"nctId":"NCT01498861","phase":"PHASE1","title":"Drug Interaction Study Between Dolutegravir and an Oral Contraceptive Containing Norgestimate and Ethinylestradiol","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2011-12","conditions":"Infection, Human Immunodeficiency Virus","enrollment":16},{"nctId":"NCT00549666","phase":"PHASE1","title":"A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects","status":"COMPLETED","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2007-08","conditions":"Pharmacokinetics","enrollment":23},{"nctId":"NCT00320567","phase":"PHASE2","title":"The Effect of Norgestimate/Ethinyl Estradiol on Bone Density in Pediatric Subjects With Anorexia Nervosa","status":"COMPLETED","sponsor":"McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.","startDate":"","conditions":"Osteoporosis","enrollment":123},{"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":"NCT00709982","phase":"PHASE1","title":"A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM) /Ethinyl Estradiol (EE) in Healthy Women.","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2005-05","conditions":"Drug Interactions, Healthy, Pharmacokinetics","enrollment":47},{"nctId":"NCT00709189","phase":"PHASE1","title":"Bioequivalence Study of the Oral Contraceptive 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":"2005-05","conditions":"Female Contraception, Contraception, Therapeutic Equivalency","enrollment":53},{"nctId":"NCT00709332","phase":"PHASE1","title":"A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) in Healthy Women.","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2005-01","conditions":"Drug Interactions, Contraception, Pharmacokinetics","enrollment":47},{"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},{"nctId":"NCT00439972","phase":"PHASE2","title":"Oral Versus Patch Hormonal Contraceptive Effects on Metabolism, Clotting, Inflammatory Factors and Vascular Reactivity","status":"UNKNOWN","sponsor":"University of Washington","startDate":"2007-02","conditions":"Contraception","enrollment":36},{"nctId":"NCT01063023","phase":"PHASE1","title":"Drug Interaction Oral Contraceptive Pill (OCP)","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2010-01","conditions":"Hepatitis C Virus","enrollment":20},{"nctId":"NCT00901290","phase":"PHASE1","title":"Determine the Effects of C-administration of AZD7325 and an Oral Contraceptive in Healthy Female Subjects","status":"SUSPENDED","sponsor":"AstraZeneca","startDate":"2009-05","conditions":"Pharmacokinetics","enrollment":56},{"nctId":"NCT00554632","phase":"NA","title":"Birth Control Pill vs Birth Control Patch Study","status":"COMPLETED","sponsor":"University of Vermont","startDate":"2003-04","conditions":"Venous Thrombosis","enrollment":24}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":31,"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","genericName":"Ortho Tri Cyclen","companyName":"Virginia Commonwealth University","companyId":"virginia-commonwealth-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ortho Tri-Cyclen 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":2,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1992-07-03T00:00:00.000Z","mah":"JANSSEN PHARMS","brand_name_local":"ORTHO TRI-CYCLEN","application_number":"NDA019697"}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}