{"id":"transdermal-contraceptive","safety":{"commonSideEffects":[{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Breast tenderness"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Application site reaction"},{"rate":null,"effect":"Breakthrough bleeding"}]},"_chembl":{"chemblId":"CHEMBL1230314","moleculeType":"Small molecule","molecularWeight":"304.39"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The patch releases a combination of ethinyl estradiol and norelgestromin (or similar progestin) through the skin into systemic circulation. These hormones suppress the luteinizing hormone (LH) surge needed for ovulation and thicken cervical mucus to prevent sperm penetration. The transdermal route provides steady hormone levels over a weekly application cycle, avoiding first-pass hepatic metabolism.","oneSentence":"A transdermal patch that delivers contraceptive hormones through the skin to prevent ovulation and pregnancy.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:13:39.803Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Prevention of pregnancy in women of reproductive age"}]},"trialDetails":[{"nctId":"NCT06672016","phase":"PHASE3","title":"Study to Evaluate Contraceptive Efficacy and Safety of a Progestin Only Patch in Women of Childbearing Potential","status":"RECRUITING","sponsor":"Mylan Pharmaceuticals Inc","startDate":"2025-01-13","conditions":"Female Contraception","enrollment":1500},{"nctId":"NCT03947684","phase":"","title":"Exploring the Modulatory Role of Sex Hormones Along the Neuromechanical Axis in Females","status":"COMPLETED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2019-04-12","conditions":"Role of Sex Hormones Along the Neuromechanical Axis","enrollment":102},{"nctId":"NCT07365904","phase":"PHASE2","title":"Investigating Ovulation Inhibition for Use as a Contraceptive","status":"RECRUITING","sponsor":"Mylan Pharmaceuticals Inc","startDate":"2025-12-22","conditions":"Contraception","enrollment":60},{"nctId":"NCT07010146","phase":"PHASE2","title":"Role of Estrogen on Skeletal Outcomes in FHA","status":"RECRUITING","sponsor":"University of Virginia","startDate":"2025-07-01","conditions":"Bone Strength, Bone Density, FHA (Functional Hypothalamic Amenorrhea)","enrollment":150},{"nctId":"NCT07083635","phase":"PHASE2","title":"Transdermal Ethinyl Estradiol and Norelgestromin for Irregular Bleeding in Contraceptive Implant Users","status":"RECRUITING","sponsor":"Chulalongkorn University","startDate":"2025-07-29","conditions":"Menstruation Disturbances, Metrorrhagia, Uterine Hemorrhage","enrollment":40},{"nctId":"NCT05704036","phase":"PHASE4","title":"Estrogen Supplementation and Bone Health in Women With CF","status":"RECRUITING","sponsor":"Johns Hopkins University","startDate":"2023-05-02","conditions":"Cystic Fibrosis, Hypoestrogenism","enrollment":75},{"nctId":"NCT04017195","phase":"PHASE1","title":"A Study of New Transdermal Contraceptive Patch at End of Shelf Life and Currently Marketed EVRA at the Beginning of Shelf Life in Healthy Women","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2019-07-12","conditions":"Healthy","enrollment":68},{"nctId":"NCT06909695","phase":"","title":"Influences of Long-acting Reversible Contraceptives on Iron Status and Physiological Responses to Extreme Environments in Women","status":"RECRUITING","sponsor":"United States Army Research Institute of Environmental Medicine","startDate":"2024-11-01","conditions":"Contraception, Iron Deficiencies","enrollment":33},{"nctId":"NCT03274297","phase":"PHASE4","title":"A Study to Evaluate Bioequivalence and Adhesion of a Transdermal Contraceptive Patch Manufactured With Newly Sourced Adhesive Components and Currently Marketed EVRA in Healthy Adult Women","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2017-09-20","conditions":"Healthy","enrollment":70},{"nctId":"NCT05139121","phase":"PHASE3","title":"Study of the Safety and Efficacy of MR-100A-01 in Approximately 1200 Healthy Women for up to 13 Cycles","status":"COMPLETED","sponsor":"Mylan Technologies Inc.","startDate":"2021-10-26","conditions":"Contraception","enrollment":1319},{"nctId":"NCT06048536","phase":"PHASE2","title":"Dose-finding Study of MR-130A-01 Contraceptive Transdermal Patch","status":"COMPLETED","sponsor":"Mylan Pharmaceuticals Inc","startDate":"2023-12-22","conditions":"Contraception","enrollment":168},{"nctId":"NCT04568980","phase":"","title":"Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis","status":"COMPLETED","sponsor":"University of Washington","startDate":"2020-09-30","conditions":"Cystic Fibrosis, Contraception","enrollment":562},{"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":"NCT00125983","phase":"PHASE2","title":"Drug Interactions Between Lopinavir/Ritonavir and Oral or Patch Contraceptives in HIV Infected Women","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"","conditions":"HIV Infections, Pregnancy","enrollment":32},{"nctId":"NCT00910637","phase":"PHASE3","title":"Study Investigating the Efficacy and Safety of a Contraceptive Patch for 13 Cycles","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-05-01","conditions":"Contraception","enrollment":1502},{"nctId":"NCT02577913","phase":"","title":"European Active Surveillance Study Comparing Regimens of Administration in Combined Hormonal Contraception","status":"TERMINATED","sponsor":"Center for Epidemiology and Health Research, Germany","startDate":"2015-11","conditions":"Contraception","enrollment":2281},{"nctId":"NCT02158572","phase":"PHASE3","title":"Efficacy, Safety and Tolerability Study of Agile AG200-15 Transdermal Contraceptive Delivery System","status":"COMPLETED","sponsor":"Agile Therapeutics","startDate":"2014-08","conditions":"Healthy","enrollment":2032},{"nctId":"NCT02367833","phase":"PHASE4","title":"Effects of Oral vs. Non-oral Contraceptives on the GH/IGF-1 Axis","status":"COMPLETED","sponsor":"Penn State University","startDate":"2015-01","conditions":"Bone; Disorder, Development and Growth","enrollment":60},{"nctId":"NCT00235547","phase":"NA","title":"Trial of Immediate Versus Delayed Initiation of Transdermal Hormonal Contraception After Therapeutic Abortion","status":"COMPLETED","sponsor":"University of California, San Francisco","startDate":"2005-08","conditions":"Abortion","enrollment":298},{"nctId":"NCT02922348","phase":"PHASE3","title":"Hormone Replacement for Premature Ovarian Insufficiency","status":"WITHDRAWN","sponsor":"University of Pennsylvania","startDate":"2016-03-01","conditions":"Primary Ovarian Insufficiency","enrollment":""},{"nctId":"NCT01422135","phase":"PHASE1","title":"Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females","status":"COMPLETED","sponsor":"Agile Therapeutics","startDate":"2011-02","conditions":"Healthy","enrollment":24},{"nctId":"NCT01375946","phase":"PHASE1","title":"Pharmacokinetic Study Of AGILE AG200-15 After Weekly Application Under Various Conditions in Healthy Female Volunteers","status":"COMPLETED","sponsor":"Agile Therapeutics","startDate":"2011-05","conditions":"Healthy","enrollment":24},{"nctId":"NCT01250210","phase":"PHASE2","title":"Evaluation of Pharmacodynamic Effects on Ovulation and Cycle Control","status":"COMPLETED","sponsor":"Agile Therapeutics","startDate":"2007-09","conditions":"Ovulation Suppression","enrollment":123},{"nctId":"NCT01181479","phase":"PHASE3","title":"Study to Evaluate the Contraceptive Efficacy/Safety of a Low Dose EE/LNG Transdermal Contraceptive Delivery System","status":"COMPLETED","sponsor":"Agile Therapeutics","startDate":"2010-08","conditions":"Contraception","enrollment":1504},{"nctId":"NCT01623466","phase":"PHASE1, PHASE2","title":"Study to Evaluate Pharmacokinetics Profile, Wearability, and Safety of 2 Progestin-Only Patches","status":"COMPLETED","sponsor":"Agile Therapeutics","startDate":"2012-07","conditions":"Healthy","enrollment":36},{"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":"NCT01236768","phase":"PHASE3","title":"Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm","status":"COMPLETED","sponsor":"Agile Therapeutics","startDate":"2010-10","conditions":"Contraception","enrollment":407},{"nctId":"NCT02550977","phase":"PHASE2","title":"Russia/Ukraine Suppression of Ovarian Activity Study","status":"COMPLETED","sponsor":"Bayer","startDate":"2015-09-18","conditions":"Contraception","enrollment":91},{"nctId":"NCT01546454","phase":"NA","title":"Relationship Between the Menstrual Cycle and Heart Disease in Women","status":"COMPLETED","sponsor":"Oregon Health and Science University","startDate":"2012-02","conditions":"Coronary Heart Disease","enrollment":5},{"nctId":"NCT00377988","phase":"","title":"A Postmarketing Study of the Risk of Venous Thromboembolism (Blood Clots), Myocardial Infarction (Heart Attacks), and Stroke Among Women Using ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared With Women Who Take Oral Contraceptives for Birth Control","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2002-04","conditions":"Contraception, Female Contraception","enrollment":423},{"nctId":"NCT00331071","phase":"","title":"Postmarketing Study of ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) in Relation to Venous Thromboembolism (Blood Clots), Stroke and Heart Attacks","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2002-04","conditions":"Contraception, Female Contraception","enrollment":334},{"nctId":"NCT00511784","phase":"","title":"Relative Risks for Non-fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction in Users of ORTHO EVRA(Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared to Levonorgestrel-containing Oral Contraceptives.","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2006-11","conditions":"Contraception, Female Contraception, Fertility Control","enrollment":440},{"nctId":"NCT00920985","phase":"PHASE3","title":"US Cycle Control and Blood Pressure Study","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-06","conditions":"Contraception","enrollment":346},{"nctId":"NCT00914693","phase":"PHASE3","title":"EU/LA Pearl Index Study - Transdermal Contraceptive Patch","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-04","conditions":"Contraception","enrollment":1694},{"nctId":"NCT00896571","phase":"PHASE2","title":"Transdermal Contraceptive Patch - Endometrial Effects Study","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-07","conditions":"Contraception","enrollment":92},{"nctId":"NCT00933179","phase":"PHASE2","title":"FC Patch Low: Metabolism Study","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-06","conditions":"Contraception","enrollment":30},{"nctId":"NCT01204190","phase":"PHASE2","title":"Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.","status":"COMPLETED","sponsor":"Bayer","startDate":"2010-09","conditions":"Contraception","enrollment":173},{"nctId":"NCT00307632","phase":"PHASE4","title":"An Open-label Study to Evaluate Contraceptive Efficacy and Safety of the Transdermal Contraceptive System of Norelgestromine and Ethinyl Estradiol","status":"COMPLETED","sponsor":"Janssen-Cilag Farmaceutica Ltda.","startDate":"2003-02","conditions":"Contraception","enrollment":580},{"nctId":"NCT00984789","phase":"PHASE3","title":"Birth Control Patch Study","status":"COMPLETED","sponsor":"Bayer","startDate":"2009-05","conditions":"Contraception","enrollment":393},{"nctId":"NCT01310647","phase":"PHASE2","title":"Antral Follicle Priming Prior to ICSI (Intracytoplasmic Sperm Injection) in Previously Diagnosed Low Responders","status":"COMPLETED","sponsor":"Instituto de Investigacion Sanitaria La Fe","startDate":"2011-06","conditions":"Ovarian Diseases","enrollment":66},{"nctId":"NCT00490555","phase":"PHASE2, PHASE3","title":"PROS-1-Male Hormonal Contraceptive Regimens on Prostate Tissue","status":"COMPLETED","sponsor":"University of Washington","startDate":"2009-01","conditions":"Healthy","enrollment":32},{"nctId":"NCT01140217","phase":"PHASE3","title":"Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception","status":"COMPLETED","sponsor":"Watson Pharmaceuticals","startDate":"2010-05","conditions":"Contraceptive Usage","enrollment":1659},{"nctId":"NCT00826839","phase":"PHASE4","title":"Oral Microdose Lupron Versus Luteal Estradiol Trial in Poor Responder In Vitro Fertilization (IVF) Patients","status":"WITHDRAWN","sponsor":"Weill Medical College of Cornell University","startDate":"2009-01","conditions":"Infertility","enrollment":""},{"nctId":"NCT01535820","phase":"PHASE1","title":"The Effect of an Adhesive Overlay on the Delivery of Contraceptive Hormones From ORTHO EVRA® in Healthy Women","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2011-03","conditions":"Healthy Volunteers","enrollment":54},{"nctId":"NCT00258076","phase":"PHASE1","title":"A Study to Evaluate the Hormone Exposure From Multiple Commercial Lots of ORTHO EVRA (a Transdermal Contraceptive Patch)","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2004-04","conditions":"Contraception, Female Contraception","enrollment":53},{"nctId":"NCT01087879","phase":"NA","title":"The Effect of Hormonal Contraceptives on Androgens and Glucose Metabolism","status":"COMPLETED","sponsor":"University of Oulu","startDate":"2007-10","conditions":"Contraception","enrollment":45},{"nctId":"NCT00775086","phase":"PHASE1","title":"Bioequivalence Study of Patches With Different Equilibration Profiles","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2004-05","conditions":"Female Contraception","enrollment":42},{"nctId":"NCT00236795","phase":"PHASE3","title":"A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Triphasil.","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"1997-01","conditions":"Contraception, Female Contraception","enrollment":1494},{"nctId":"NCT00236782","phase":"PHASE3","title":"A Study of Efficacy and Safety With the Transdermal Contraceptive System Versus Mercilon.","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"1997-10","conditions":"Contraception","enrollment":1517},{"nctId":"NCT00258063","phase":"PHASE1","title":"A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA (a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme) and CILEST (an Oral Contraceptive)","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2004-05","conditions":"Contraception, Female Contraception","enrollment":60},{"nctId":"NCT00697307","phase":"","title":"Bioequivalence Study of Patches With Different Release Profiles","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2003-03","conditions":"Female Contraception","enrollment":43},{"nctId":"NCT00254865","phase":"PHASE1","title":"A Comparative Pharmacokinetic Study of ORTHO EVRA (a Transdermal Contraceptive Patch) and CILEST (an Oral Contraceptive) in Healthy Female Volunteers","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2002-08","conditions":"Contraception, Female Contraception","enrollment":34},{"nctId":"NCT00236769","phase":"PHASE3","title":"A Study of Efficacy and Safety With the Transdermal Contraceptive System.","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"1997-11","conditions":"Contraception, Female Contraception","enrollment":1751},{"nctId":"NCT00261482","phase":"PHASE4","title":"Evaluation of Women's Experience With EVRA (Norelgestromin + Ethinyl Estradiol) Transdermal Contraceptive Patch Compared With Previous Methods of Contraception.","status":"COMPLETED","sponsor":"Janssen Pharmaceutica N.V., Belgium","startDate":"2003-07","conditions":"Contraception, Female Contraception","enrollment":778},{"nctId":"NCT00653016","phase":"PHASE4","title":"An Open-label, Multicentre Study on Preference and Satisfaction of Canadian Women for the Transdermal Contraceptive Patch vs. Previous Primary Contraceptive Method","status":"COMPLETED","sponsor":"Janssen-Ortho Inc., Canada","startDate":"2002-10","conditions":"Female Contraception","enrollment":405},{"nctId":"NCT00269620","phase":"PHASE4","title":"PARIS or PAtch RIng Study: A Trial to Evaluate NuvaRing Versus OrthoEvra","status":"COMPLETED","sponsor":"University of Pittsburgh","startDate":"2005-06","conditions":"Contraception","enrollment":500},{"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":104,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Xulane"],"phase":"marketed","status":"active","brandName":"Transdermal Contraceptive","genericName":"Transdermal Contraceptive","companyName":"Penn State University","companyId":"penn-state-university","modality":"Small molecule","firstApprovalDate":"","aiSummary":"A transdermal patch that delivers contraceptive hormones through the skin to prevent ovulation and pregnancy. Used for Prevention of pregnancy in women of reproductive age.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}