{"id":"estradiol-norethisterone","safety":{"commonSideEffects":[{"rate":"10-20%","effect":"Breast tenderness"},{"rate":"10-20%","effect":"Headache"},{"rate":"10-20%","effect":"Nausea"},{"rate":"5-10%","effect":"Vaginal bleeding"},{"rate":"5-10%","effect":"Abdominal cramps"}]},"_chembl":{"chemblId":"CHEMBL3187229","moleculeType":"Small molecule","molecularWeight":"410.60"},"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"Estradiol is an estrogen that helps to replace estrogen in the body, while norethisterone is a progestin that helps to regulate the menstrual cycle and prevent uterine cancer. This combination of hormones helps to alleviate symptoms of menopause and prevent osteoporosis.","oneSentence":"Estradiol-norethisterone is a combination of an estrogen and a progestin that works by replacing natural hormones in the body.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:11:37.331Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Treatment of moderate to severe vasomotor symptoms associated with menopause"},{"name":"Prevention of postmenopausal osteoporosis"}]},"trialDetails":[{"nctId":"NCT07074327","phase":"PHASE1","title":"Effects of VX-407 on the Pharmacokinetics of Oral Contraceptives in Healthy Participants","status":"ACTIVE_NOT_RECRUITING","sponsor":"Vertex Pharmaceuticals Incorporated","startDate":"2025-07-11","conditions":"Autosomal Dominant Polycystic Kidney Disease (ADPKD)","enrollment":74},{"nctId":"NCT07446400","phase":"PHASE1","title":"A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together","status":"NOT_YET_RECRUITING","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","startDate":"2026-03-20","conditions":"Healthy Volunteers","enrollment":48},{"nctId":"NCT03905941","phase":"EARLY_PHASE1","title":"Relative Desirability of Metformin vs. Birth Control Pill in Treating PCOS in Women of Later Reproductive Age","status":"WITHDRAWN","sponsor":"University of Virginia","startDate":"2021-08-23","conditions":"Polycystic Ovary Syndrome","enrollment":""},{"nctId":"NCT07100782","phase":"PHASE3","title":"Estradiol-mediated Inflammation and Central Sensitization in the Pathophysiology of Endometriosis-associated Pelvic Pain","status":"RECRUITING","sponsor":"University of Michigan","startDate":"2025-12-08","conditions":"Endometriosis, Pelvic Pain","enrollment":130},{"nctId":"NCT04756037","phase":"PHASE3","title":"Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sumitomo Pharma Switzerland GmbH","startDate":"2021-03-18","conditions":"Contraception","enrollment":1020},{"nctId":"NCT03106454","phase":"PHASE3","title":"Ovulation Incidence in Oral Contraceptive Users","status":"COMPLETED","sponsor":"University of Southern California","startDate":"2014-08","conditions":"Contraception, Ovulation","enrollment":58},{"nctId":"NCT07215806","phase":"PHASE1","title":"Effect of Evobrutinib on Pharmacokinetics of a Combined Oral Contraceptive","status":"COMPLETED","sponsor":"Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany","startDate":"2022-08-24","conditions":"Healthy","enrollment":20},{"nctId":"NCT05538689","phase":"PHASE4","title":"Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL)","status":"WITHDRAWN","sponsor":"University of Chicago","startDate":"2022-11-20","conditions":"Metrorrhagia, Pelvic Pain, Menorrhagia","enrollment":""},{"nctId":"NCT06058728","phase":"","title":"A Study to Evaluate Changes in Hair in Adult Participants Taking Oral Oriahnn Capsules With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)","status":"WITHDRAWN","sponsor":"AbbVie","startDate":"2023-12-20","conditions":"Uterine Fibroids (UF)","enrollment":""},{"nctId":"NCT06279195","phase":"PHASE2","title":"Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment","status":"WITHDRAWN","sponsor":"Endeavor Health","startDate":"2024-06-01","conditions":"Pelvic Pain","enrollment":""},{"nctId":"NCT06186271","phase":"","title":"International Active Surveillance Study: Safety of Estrogen Estetrol (E4) Contraceptive Study (INAS-SEECS)","status":"RECRUITING","sponsor":"Center for Epidemiology and Health Research, Germany","startDate":"2025-04-24","conditions":"Contraception","enrollment":68100},{"nctId":"NCT06953076","phase":"","title":"Ultrasound Transformation of Myomas During Relugolix-Estradiol-Norethisterone Treatment: The MySaturn Study","status":"RECRUITING","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","startDate":"2025-05-02","conditions":"Uterine Bleeding, Uterine Leiomyomas, Uterine Hemorrhage","enrollment":111},{"nctId":"NCT05862272","phase":"PHASE3","title":"A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis","status":"RECRUITING","sponsor":"Sumitomo Pharma Switzerland GmbH","startDate":"2023-08-14","conditions":"Uterine Fibroids, Endometriosis","enrollment":1000},{"nctId":"NCT05739136","phase":"","title":"MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy","status":"ACTIVE_NOT_RECRUITING","sponsor":"Sumitomo Pharma Switzerland GmbH","startDate":"2025-04-30","conditions":"Pregnancy Related, Pregnancy Complications, Pregnancy, High Risk","enrollment":530},{"nctId":"NCT03271489","phase":"PHASE3","title":"Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women","status":"COMPLETED","sponsor":"AbbVie","startDate":"2017-09-13","conditions":"Heavy Menstrual Bleeding, Uterine Fibroids","enrollment":478},{"nctId":"NCT01246791","phase":"PHASE3","title":"Pharmacokinetics of NPC-01 After Single Oral Administration in Healthy Female Volunteers","status":"COMPLETED","sponsor":"Nobelpharma","startDate":"2010-11","conditions":"Healthy","enrollment":12},{"nctId":"NCT00902746","phase":"PHASE3","title":"Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis","status":"COMPLETED","sponsor":"Nobelpharma","startDate":"2009-05","conditions":"Dysmenorrhea","enrollment":149},{"nctId":"NCT06439524","phase":"PHASE3","title":"The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial","status":"RECRUITING","sponsor":"Main Line Health","startDate":"2024-08-15","conditions":"Endometriosis","enrollment":110},{"nctId":"NCT02636972","phase":"","title":"The Progression From Dysmenorrhoea to Chronic Pelvic Pain","status":"COMPLETED","sponsor":"University of Adelaide","startDate":"2014-11","conditions":"Dysmenorrhoea, Pelvic Pain, Chronic Pain","enrollment":56},{"nctId":"NCT00746096","phase":"PHASE3","title":"Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea","status":"COMPLETED","sponsor":"Nobelpharma","startDate":"2008-09","conditions":"Dysmenorrhea","enrollment":115},{"nctId":"NCT01253824","phase":"PHASE3","title":"Pharmacodynamics of NPC-01/IKH-01; Effect of NPC-01/IKH-01 on Sexual Hormone Concentrations in Healthy Female Volunteers","status":"COMPLETED","sponsor":"Nobelpharma","startDate":"2011-01","conditions":"Healthy","enrollment":14},{"nctId":"NCT01129102","phase":"PHASE3","title":"Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea","status":"COMPLETED","sponsor":"Nobelpharma","startDate":"2010-05","conditions":"Dysmenorrhea","enrollment":215},{"nctId":"NCT06460948","phase":"EARLY_PHASE1","title":"Identifying Oxytocin Deficiency in Adults With Pituitary Disease","status":"RECRUITING","sponsor":"Elizabeth Austen Lawson","startDate":"2024-11-13","conditions":"Arginine Vasopressin Deficiency, Oxytocin Deficiency","enrollment":32},{"nctId":"NCT03213457","phase":"PHASE3","title":"A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain","status":"COMPLETED","sponsor":"AbbVie","startDate":"2017-07-07","conditions":"Endometriosis","enrollment":681},{"nctId":"NCT06310616","phase":"PHASE1","title":"A Study to Investigate the Potential Drug-Drug Interaction Between VH4524184 and Oral Contraceptive (Loestrin) in Healthy Adult Female Participants","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2024-03-06","conditions":"HIV Infections","enrollment":26},{"nctId":"NCT03751124","phase":"PHASE3","title":"Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2018-10-16","conditions":"Uterine Leiomyoma, Uterine Fibroids","enrollment":229},{"nctId":"NCT01656434","phase":"PHASE3","title":"Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448)","status":"TERMINATED","sponsor":"Organon and Co","startDate":"2012-11-02","conditions":"Contraception","enrollment":3173},{"nctId":"NCT05586724","phase":"PHASE3","title":"Micronized Progesterone Versus Norethisterone Acetate in Combination With Estrogen as Menopausal Hormone Therapy","status":"RECRUITING","sponsor":"Angelica Lindén Hirschberg","startDate":"2022-03-15","conditions":"Menopausal Symptoms","enrollment":520},{"nctId":"NCT03412890","phase":"PHASE3","title":"LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2017-10-19","conditions":"Heavy Menstrual Bleeding, Uterine Fibroid","enrollment":477},{"nctId":"NCT06358014","phase":"NA","title":"Assessment of the Improvement in Cognitive Levels of Postmenopausal Depression Patients by Estrogen","status":"RECRUITING","sponsor":"Xiao Wang","startDate":"2023-05-12","conditions":"Postmenopausal Depression, Estrogen","enrollment":40},{"nctId":"NCT05891262","phase":"PHASE1","title":"A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2023-06-06","conditions":"Healthy Female Volunteers","enrollment":15},{"nctId":"NCT05579574","phase":"PHASE1","title":"A Study to Investigate the Interaction of BMS-986322 and a Combined Oral Hormonal Contraceptive (Ethinyl Estradiol [EE]/Norethindrone [NET]) in Healthy Female Participants","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2022-10-21","conditions":"Healthy Participants","enrollment":42},{"nctId":"NCT05026502","phase":"","title":"A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules","status":"TERMINATED","sponsor":"AbbVie","startDate":"2021-10-05","conditions":"Heavy Menstrual Bleeding, Uterine Fibroids","enrollment":23},{"nctId":"NCT03654274","phase":"PHASE3","title":"SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2018-05-22","conditions":"Endometriosis","enrollment":802},{"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":"NCT05620355","phase":"PHASE3","title":"Efficacy and Safety of BG2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids.","status":"UNKNOWN","sponsor":"Bio Genuine (Shanghai) Biotech Co., Ltd.","startDate":"2022-12-16","conditions":"Uterine Fibroids, Heavy Menstrual Bleeding","enrollment":312},{"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":"NCT04016753","phase":"PHASE1","title":"A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2019-08-05","conditions":"Healthy Participants","enrollment":32},{"nctId":"NCT04856306","phase":"","title":"Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-L","status":"UNKNOWN","sponsor":"Medstar Health Research Institute","startDate":"2021-04-12","conditions":"Heavy Menstrual Bleeding, Fibroid Uterus","enrollment":300},{"nctId":"NCT03103087","phase":"PHASE3","title":"LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2017-06-14","conditions":"Heavy Menstrual Bleeding, Uterine Fibroid","enrollment":382},{"nctId":"NCT03049735","phase":"PHASE3","title":"LIBERTY 1: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2017-04-26","conditions":"Heavy Menstrual Bleeding, Uterine Fibroid","enrollment":388},{"nctId":"NCT04934696","phase":"PHASE1","title":"A Study to Characterize the Drug Levels of an Oral Contraceptive With and Without BMS-986166 in Healthy Female Participants of Childbearing Potential","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2021-08-03","conditions":"Healthy Participants","enrollment":25},{"nctId":"NCT02705963","phase":"PHASE1","title":"A Drug-Drug Interaction Study to Assess the Effect of Trametinib on the Pharmacokinetics of an Oral Contraceptive in Female Patients With Solid Tumors","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2016-10-20","conditions":"Solid Tumors","enrollment":19},{"nctId":"NCT00413764","phase":"PHASE3","title":"Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2004-03-23","conditions":"Sexual Dysfunction","enrollment":358},{"nctId":"NCT00431093","phase":"PHASE4","title":"Trial to Compare the Effects of Tibolone (Livial®) and Continuous Combined Low-Dose Estradiol/Noresterone (Activelle®)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-11","conditions":"Menopause","enrollment":570},{"nctId":"NCT05135013","phase":"","title":"The Association of Hormonal Intake and Demographic Factors With Breast Cancer Risk. An Egyptian Case-controlled Study","status":"UNKNOWN","sponsor":"NewGiza University","startDate":"2021-11-16","conditions":"Observational Study","enrollment":200},{"nctId":"NCT04714554","phase":"PHASE1","title":"A Study of the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix in Healthy Adult Men","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2021-01-06","conditions":"Healthy","enrollment":43},{"nctId":"NCT02925494","phase":"PHASE3","title":"An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids","status":"COMPLETED","sponsor":"AbbVie","startDate":"2016-09-14","conditions":"Uterine Fibroids, Heavy Menstrual Bleeding","enrollment":433},{"nctId":"NCT02691494","phase":"PHASE3","title":"Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)","status":"COMPLETED","sponsor":"AbbVie","startDate":"2016-02-03","conditions":"Uterine Fibroids, Heavy Menstrual Bleeding","enrollment":378},{"nctId":"NCT01441635","phase":"PHASE2","title":"Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids","status":"COMPLETED","sponsor":"AbbVie (prior sponsor, Abbott)","startDate":"2011-09-08","conditions":"Heavy Uterine Bleeding, Uterine Fibroids","enrollment":271},{"nctId":"NCT03204331","phase":"PHASE3","title":"SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2017-11-01","conditions":"Endometriosis Related Pain","enrollment":623},{"nctId":"NCT03204318","phase":"PHASE3","title":"SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain","status":"COMPLETED","sponsor":"Myovant Sciences GmbH","startDate":"2017-12-07","conditions":"Endometriosis Related Pain","enrollment":638},{"nctId":"NCT03946722","phase":"PHASE4","title":"Modified Downregulation for Women With Adenomyosis of the Uterus Prior to Frozen-thawed Embryo Transfer.","status":"UNKNOWN","sponsor":"University College, London","startDate":"2020-08-17","conditions":"Adenomyosis","enrollment":162},{"nctId":"NCT04709094","phase":"PHASE1","title":"A Drug Interaction Study of Danicopan","status":"COMPLETED","sponsor":"Alexion Pharmaceuticals, Inc.","startDate":"2019-07-28","conditions":"Healthy","enrollment":52},{"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":"NCT02036879","phase":"EARLY_PHASE1","title":"Gender Disparity and Hormones in Cystic Fibrosis","status":"COMPLETED","sponsor":"University of Texas Southwestern Medical Center","startDate":"2014-02","conditions":"Cystic Fibrosis (CF)","enrollment":55},{"nctId":"NCT01817530","phase":"PHASE2","title":"Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)","status":"COMPLETED","sponsor":"AbbVie","startDate":"2013-04-08","conditions":"Heavy Uterine Bleeding, Uterine Fibroids","enrollment":571},{"nctId":"NCT04424173","phase":"","title":"Combined Hormone Therapy, C-reactive Protein(CRP) Levels and Life Quality in Natural Menopause Women","status":"COMPLETED","sponsor":"Karadeniz Technical University","startDate":"2007-08-01","conditions":"CRP, Menopause","enrollment":45},{"nctId":"NCT02654054","phase":"PHASE3","title":"Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women","status":"COMPLETED","sponsor":"AbbVie","startDate":"2015-12-22","conditions":"Uterine Fibroids, Heavy Menstrual Bleeding","enrollment":413},{"nctId":"NCT03353857","phase":"PHASE1","title":"Drug-drug Interaction Between Rifampicin and Progestins/Ethinylestradiol and Midazolam","status":"COMPLETED","sponsor":"Bayer","startDate":"2017-11-29","conditions":"Biological Availability","enrollment":68},{"nctId":"NCT03262740","phase":"PHASE1","title":"The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2017-09-11","conditions":"Rheumatoid Arthritis","enrollment":58},{"nctId":"NCT03262727","phase":"PHASE1","title":"The Effect of BMS-986165 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2017-09-01","conditions":"Systemic Lupus Erythematosus, Arthritic Psoriasis, Psoriasis","enrollment":49},{"nctId":"NCT03343067","phase":"PHASE3","title":"A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe Pain","status":"TERMINATED","sponsor":"AbbVie","startDate":"2017-12-27","conditions":"Endometriosis","enrollment":11},{"nctId":"NCT01466114","phase":"PHASE2","title":"Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition","status":"UNKNOWN","sponsor":"University of California, Los Angeles","startDate":"2011-10","conditions":"Relapsing-remitting Multiple Sclerosis, Secondary-progressive Multiple Sclerosis, Primary-progressive Multiple Sclerosis","enrollment":64},{"nctId":"NCT02969590","phase":"PHASE4","title":"Regulation of Cervical Mucus Secretion","status":"COMPLETED","sponsor":"Oregon Health and Science University","startDate":"2015-03-29","conditions":"Fertility, Contraception","enrollment":5},{"nctId":"NCT03856970","phase":"PHASE1","title":"Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers","status":"COMPLETED","sponsor":"Ironwood Pharmaceuticals, Inc.","startDate":"2019-03-11","conditions":"Healthy Volunteers","enrollment":87},{"nctId":"NCT01953211","phase":"","title":"Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity","status":"COMPLETED","sponsor":"University of Southern California","startDate":"","conditions":"Hypothalamic-pituitary-ovarian Axis, Gonadotropins, Ethinyl Estradiol, Contraceptive Efficacy","enrollment":64},{"nctId":"NCT00600106","phase":"NA","title":"Data Analyses for Ancillary WISE Femhrt Hormone Replacement Study","status":"COMPLETED","sponsor":"Cedars-Sinai Medical Center","startDate":"1999-12","conditions":"Myocardial Ischemia","enrollment":37},{"nctId":"NCT03921736","phase":"PHASE4","title":"Reversal of an Unfavorable Effect of Hydrochlorothiazide Compared to Angiotensin Converting Enzyme Inhibitor on Serum Uric Acid and Oxypurines Levels by Estrogen-progestin Therapy in Hypertensive Postmenopausal Women.","status":"COMPLETED","sponsor":"Anna Posadzy-Małaczyńska","startDate":"2000-01-10","conditions":"Hypertension, Hyperuricemia, Menopause","enrollment":180},{"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":"NCT03451110","phase":"PHASE1","title":"Study to Assess the Pharmacokinetic Drug-Drug Interactions of Lemborexant When Coadministered With an Oral Contraceptive, Famotidine, or Fluconazole in Healthy Subjects","status":"COMPLETED","sponsor":"Eisai Inc.","startDate":"2018-02-05","conditions":"Healthy Subjects","enrollment":50},{"nctId":"NCT02693002","phase":"PHASE4","title":"Estrogen Diastolic Heart Failure","status":"TERMINATED","sponsor":"Gretchen Wells","startDate":"2016-02","conditions":"Menopause","enrollment":4},{"nctId":"NCT02480881","phase":"PHASE1","title":"A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)","status":"COMPLETED","sponsor":"ViiV Healthcare","startDate":"2015-07-07","conditions":"Infection, Human Immunodeficiency Virus","enrollment":26},{"nctId":"NCT01077505","phase":"PHASE1","title":"An Evaluation of the Pharmacokinetics of an Oral Contraceptive (Brevicon) When Co-administered With Albiglutide .","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-03-15","conditions":"Diabetes Mellitus, Type 2","enrollment":16},{"nctId":"NCT01705249","phase":"PHASE4","title":"Bleeding Profile With Continuous Hormone Replacement Therapy of Activelle® in Postmenopausal Women","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2001-08-14","conditions":"Menopause, Healthy","enrollment":191},{"nctId":"NCT00184795","phase":"PHASE3","title":"Bleed Free Treatment of Menopausal Symptoms With New Ultra Low Dose Hormonal Combinations","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2004-05-28","conditions":"Menopause, Menopausal Vasomotor Symptoms","enrollment":576},{"nctId":"NCT02832180","phase":"PHASE1","title":"The Effect of BMS-986142 on the Pharmacokinetics of a Combined Oral Contraceptive (OC) Containing Ethinyl Estradiol (EE) and Norethindrone Acetate (NET) in Healthy Female Subjects","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2016-05","conditions":"Arthritis","enrollment":25},{"nctId":"NCT02652650","phase":"PHASE1","title":"A Study to Investigate the Effect of JNJ-63623872 at Steady-state on the Steady-state Pharmacokinetics of Ethinylestradiol and Norethindrone","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2015-12","conditions":"Healthy","enrollment":18},{"nctId":"NCT01465022","phase":"NA","title":"Breastfeeding and Oral Contraceptives: a Randomized, Controlled Trial","status":"COMPLETED","sponsor":"University of New Mexico","startDate":"2005-01","conditions":"Breast Feeding, Contraception","enrollment":197},{"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},{"nctId":"NCT02292732","phase":"PHASE1","title":"A Pharmacokinetics (PK) and Safety Study to Determine the Effect of Repeat Dosing of Trametinib on Combined Oral Contraceptive (Norethindrone Plus Ethinyl Estradiol) in Female Subjects With Solid Tumors","status":"WITHDRAWN","sponsor":"GlaxoSmithKline","startDate":"2016-02","conditions":"Cancer","enrollment":""},{"nctId":"NCT01477632","phase":"PHASE1","title":"Bioavailability of Three Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2005-03","conditions":"Menopause, Healthy","enrollment":24},{"nctId":"NCT01209143","phase":"PHASE1","title":"A Study of Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists","status":"COMPLETED","sponsor":"Genentech, Inc.","startDate":"2010-11","conditions":"Solid Cancers","enrollment":52},{"nctId":"NCT00474851","phase":"PHASE2","title":"The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial","status":"COMPLETED","sponsor":"Boston Children's Hospital","startDate":"2007-08","conditions":"Endometriosis","enrollment":53},{"nctId":"NCT01596010","phase":"PHASE1","title":"Investigation of 2 Different Oral Formulations of Estradiol and Norethisterone in Healthy Women","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2007-10","conditions":"Menopause, Healthy","enrollment":44},{"nctId":"NCT00350480","phase":"NA","title":"Treatment of Non-Gestational Acute Uterine Bleeding: A Randomized Trial","status":"COMPLETED","sponsor":"Kaiser Permanente","startDate":"2003-04","conditions":"Uterine Hemorrhage, Menorrhagia","enrollment":240},{"nctId":"NCT01953809","phase":"PHASE1","title":"A Pharmacokinetics, Pharmacodynamics, and Safety Study of an Oral Contraceptive Containing Norethindrone and Ethinyl Estradiol When Co-administered With GSK1322322 in Healthy Adult Women","status":"WITHDRAWN","sponsor":"GlaxoSmithKline","startDate":"2014-08","conditions":"Infections, Bacterial","enrollment":""},{"nctId":"NCT00522873","phase":"PHASE3","title":"Endometrial Safety Study","status":"COMPLETED","sponsor":"Bayer","startDate":"2007-08","conditions":"Postmenopause","enrollment":662},{"nctId":"NCT01076621","phase":"","title":"Observational Study to Investigate the Occurrence of Bleeding in Postmenopausal Women Treated With Estradiol/NETA for 12 Months","status":"COMPLETED","sponsor":"Novo Nordisk A/S","startDate":"2010-05","conditions":"Menopause, Postmenopausal Bleeding","enrollment":176},{"nctId":"NCT02264743","phase":"PHASE4","title":"Oral Verses Patch Trial In Menopausal Women - Individualisation of Oestrogen Therapy","status":"UNKNOWN","sponsor":"Royal Brompton & Harefield NHS Foundation Trust","startDate":"2013-11","conditions":"Venous Thrombosis, Insulin Resistance","enrollment":60},{"nctId":"NCT02245438","phase":"PHASE1","title":"Effect of Tipranavir and Ritonavir on the Pharmacokinetic Characteristics of Norethindrone-Ethinyl Estradiol in Healthy Female Adult Volunteers","status":"TERMINATED","sponsor":"Boehringer Ingelheim","startDate":"2002-05","conditions":"Healthy","enrollment":52},{"nctId":"NCT02103569","phase":"PHASE1","title":"Drug Interaction Study of an OCP (Norethindrone (ND) Acetate and Ethinyl Estradiol (EE))With a Combination of Daclatasvir (DCV) Asunaprevir (ASV) and BMS-791325","status":"COMPLETED","sponsor":"Bristol-Myers Squibb","startDate":"2014-04","conditions":"Hepatitis C","enrollment":20},{"nctId":"NCT02210702","phase":"PHASE4","title":"Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales","status":"UNKNOWN","sponsor":"The Jones Institute","startDate":"2014-07","conditions":"Postpartum Depressive Mood, Postpartum Sexual Function","enrollment":33},{"nctId":"NCT02182791","phase":"PHASE1","title":"Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine (VIRAMUNE) and Ethinyl Estradiol/Norethindrone in HIV-1 Infected Women","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"1998-04","conditions":"HIV Infections","enrollment":14},{"nctId":"NCT01631981","phase":"PHASE2","title":"PGL2001 Proof of Concept Study in Symptomatic Endometriosis","status":"COMPLETED","sponsor":"PregLem SA","startDate":"2012-06","conditions":"Endometriosis","enrollment":162},{"nctId":"NCT00999479","phase":"NA","title":"Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation","status":"WITHDRAWN","sponsor":"University of Oklahoma","startDate":"2009-10","conditions":"Endometrioma","enrollment":""},{"nctId":"NCT00003771","phase":"PHASE3","title":"Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer","status":"COMPLETED","sponsor":"Regional Oncologic Center","startDate":"1997-09","conditions":"Breast Cancer, Menopausal Symptoms","enrollment":1300},{"nctId":"NCT00477633","phase":"PHASE3","title":"Study of Safety and Efficacy of an Oral Contraceptive","status":"COMPLETED","sponsor":"Warner Chilcott","startDate":"2007-06","conditions":"Contraception","enrollment":1700},{"nctId":"NCT00391807","phase":"PHASE3","title":"Study of Safety and Efficacy of an Oral Contraceptive","status":"COMPLETED","sponsor":"Warner Chilcott","startDate":"2006-11","conditions":"Contraception","enrollment":1683},{"nctId":"NCT00932321","phase":"PHASE3","title":"Study of Safety and Efficacy of an Oral Contraceptive","status":"COMPLETED","sponsor":"Warner Chilcott","startDate":"2004-01","conditions":"Prevention of Pregnancy","enrollment":938}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":71,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Combipatch®","Estalis®"],"phase":"phase_3","status":"active","brandName":"estradiol-norethisterone","genericName":"estradiol-norethisterone","companyName":"Organon and Co","companyId":"organon-and-co","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Estradiol-norethisterone is a combination of an estrogen and a progestin that works by replacing natural hormones in the body. Used for Treatment of moderate to severe vasomotor symptoms associated with menopause, Prevention of postmenopausal osteoporosis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}