{"id":"endometrin","brandName":"Endometrin","genericName":"progesterone","companyId":"ferring","companyName":"Ferring","phase":"marketed","status":"active","modality":"","aliases":[],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"","enrichmentLevel":3,"visitCount":0,"mechanism":{"target":"Corticosteroid-binding globulin, Sodium/nucleoside cotransporter 1, Cation channel sperm-associated protein 1","drugClass":"Progesterone [EPC]"},"administration":{"route":"Oral"},"safety":{"boxedWarnings":["WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY Cardiovascular Disorders and Probable Dementia Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. (See CLINICAL STUDIES and WARNINGS , Cardiovascular disorders and Probable dementia . ) The Women's Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis, pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. (See CLINICAL STUDIES and WARNINGS , Cardiovascular disorders . ) The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS, Probable dementia and PRECAUTIONS, Geriatric Use . ) Breast Cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. (See CLINICAL STUDIES and WARNINGS, Malignant neoplasms, Breast Cancer. ) In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.\nWHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT PROGESTERONE CAPSULES (A Progesterone Hormone)? Progesterone with estrogens should not be used to prevent heart disease, heart attacks, strokes, or dementia. Using progestins with estrogens may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. Using progestins with estrogens may increase your chance of getting dementia, based on a study of women age 65 and older. You and your healthcare provider should talk regularly about whether you still need treatment with progesterone capsules."],"safetySignals":[{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"2007 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"1774 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"1716 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1696 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"1397 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"1382 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"929 reports"},{"date":"","signal":"RASH","source":"FDA FAERS","actionTaken":"915 reports"},{"date":"","signal":"EXPOSURE DURING PREGNANCY","source":"FDA FAERS","actionTaken":"880 reports"},{"date":"","signal":"HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"809 reports"}],"drugInteractions":[],"commonSideEffects":[{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Fatigue","drugRate":"","severity":"common","organSystem":""},{"effect":"Vaginal mycosis","drugRate":"","severity":"common","organSystem":""},{"effect":"Nasopharyngitis","drugRate":"","severity":"common","organSystem":""},{"effect":"Upper respiratory tract infection","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Dizziness","drugRate":"","severity":"common","organSystem":""},{"effect":"Breast tenderness","drugRate":"","severity":"common","organSystem":""},{"effect":"Abdominal distension","drugRate":"","severity":"common","organSystem":""},{"effect":"Acne","drugRate":"","severity":"common","organSystem":""},{"effect":"Dysmenorrhea","drugRate":"","severity":"common","organSystem":""},{"effect":"Mood swing","drugRate":"","severity":"common","organSystem":""},{"effect":"Urinary tract infection","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Alcoholism","Anorexia nervosa","Asthma","Bed-ridden","Body fluid retention","Breast lump","Carcinoma of female breast","Cardiovascular event risk","Cerebrovascular accident","Cerebrovascular disease","Chloasma","Chorea","Chronic heart failure","Deep venous thrombosis","Dementia","Depressive disorder","Diabetes mellitus","Diplopia","Disease of liver","Disorder of coronary artery","Disorder of gallbladder","Ectopic pregnancy","Epilepsy","Estrogen receptor positive tumor","Family history of malignant neoplasm of breast","Fibroadenosis of breast","Functional visual loss","Hepatic failure","Hepatic porphyria","Humoral hypercalcemia of malignancy","Hypercholesterolemia","Hyperglycemia","Hyperlipidemia","Hyperlipoproteinemia","Hypertensive disorder","Hypertensive urgency","Hypertriglyceridemia","Hypocalcemia","Hypothyroidism","Impaired glucose tolerance","Incomplete miscarriage","Intermenstrual bleeding - irregular","Jaundice","Kidney disease","Malignant neoplasm of liver","Malignant tumor of ovary","Mammography abnormal","Migraine","Mild pre-eclampsia","Myocardial infarction","Neoplasm of liver","Obesity","Optic disc edema","Osteopenia","Osteoporosis","Porphyria","Predisposition to Thrombosis","Pregnancy, function","Pulmonary thromboembolism","Retinal hemorrhage","Seizure disorder","Smokes tobacco daily","Systemic lupus erythematosus","Thromboembolic disorder","Thrombophilia","Thrombophlebitis","Thrombosis of retinal vein","Uterine leiomyoma","Weight gain finding"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[{"effect":"Endometrial carcinoma","drugRate":"","severity":"serious"},{"effect":"Hepatic failure","drugRate":"","severity":"serious"},{"effect":"Hepatic necrosis","drugRate":"","severity":"serious"},{"effect":"Spontaneous abortion","drugRate":"","severity":"serious"},{"effect":"Intra-uterine death","drugRate":"","severity":"serious"},{"effect":"Circulatory collapse","drugRate":"","severity":"serious"},{"effect":"Loss of consciousness","drugRate":"","severity":"serious"},{"effect":"Anaphylactic reaction","drugRate":"","severity":"serious"},{"effect":"Convulsion","drugRate":"","severity":"serious"},{"effect":"Suicidal ideation","drugRate":"","severity":"serious"}]},"trials":["NCT06006091","NCT04124913","NCT03863613","NCT06979596","NCT05737329","NCT00755963","NCT05997563","NCT03422809","NCT04597099","NCT04128436","NCT02736032","NCT04152057","NCT03677336","NCT00271206","NCT01428193","NCT04453332","NCT00694967","NCT00303615","NCT02384408","NCT05075174","NCT02734290","NCT00117468","NCT05323513","NCT02798653","NCT00003953","NCT04460807","NCT02937766","NCT04686357","NCT05076981","NCT07357922","NCT02092571","NCT03774745","NCT02913495","NCT04722471","NCT00656201","NCT00446030","NCT00073528","NCT05781009","NCT07415070","NCT02852954","NCT04895358","NCT01406197","NCT03309176","NCT06807580","NCT04997525","NCT01204840","NCT00870168","NCT02579421","NCT03343912","NCT02158507"],"indications":{"approved":[{"name":"Amenorrhea Secondary to Ovarian Dysfunction","diseaseId":"amenorrhea-secondary-to-ovarian-dysfunction","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Atrophic vaginitis","diseaseId":"atrophic-vaginitis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Contraception","diseaseId":"contraception","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Corpus Luteum Insufficiency Syndrome","diseaseId":"corpus-luteum-insufficiency-syndrome","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Dysfunctional uterine bleeding","diseaseId":"dysfunctional-uterine-bleeding","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Endometrial Hyperplasia Prevention","diseaseId":"endometrial-hyperplasia-prevention","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Endometrial carcinoma","diseaseId":"endometrial-carcinoma","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Endometriosis","diseaseId":"endometriosis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Infertility Secondary to Progesterone Deficiency","diseaseId":"infertility-secondary-to-progesterone-deficiency","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Menopausal flushing","diseaseId":"menopausal-flushing","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Postmenopausal osteoporosis","diseaseId":"postmenopausal-osteoporosis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Prevention of Premature Labor","diseaseId":"prevention-of-premature-labor","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Secondary malignant neoplasm of kidney","diseaseId":"secondary-malignant-neoplasm-of-kidney","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Secondary physiologic amenorrhea","diseaseId":"secondary-physiologic-amenorrhea","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"commercial":null,"patents":[{"type":"Method of Use","number":"10548904","applicant":"FERRING PHARMACEUTICALS INC","territory":"US","tradeName":"MILPROSA","expiryDate":"2029-02-03"},{"type":"Method of Use","number":"8580293","applicant":"FERRING PHARMACEUTICALS INC","territory":"US","tradeName":"MILPROSA","expiryDate":"2030-01-21"},{"type":"Formulation","number":"10537584","applicant":"FERRING PHARMACEUTICALS INC","territory":"US","tradeName":"MILPROSA","expiryDate":"2029-02-03"}],"timeline":[],"rwe":[],"competitors":[],"ownershipHistory":[],"trialDetails":[{"nctId":"NCT06006091","phase":"NA","title":"Clinical Outcomes of Letrozole-induced Endometrial Preparation Regimens Versus Conventional Endometrial Preparation Regimens Including Natural Cycle, Hormone Replacement Regimens in FET, a Randomized ","status":"RECRUITING","sponsor":"International Peace Maternity and Child Health Hospital","isPivotal":false,"enrollment":858,"indication":"Letrozole, Infertility, Female","completionDate":"2027-08-01"},{"nctId":"NCT04124913","phase":"Phase 4","title":"Comparison of Oral Dydrogesterone Versus Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles: a Randomized Controlled Trial","status":"UNKNOWN","sponsor":"Memorial Sisli Hospital, Istanbul","isPivotal":false,"enrollment":140,"indication":"Infertility, Female, Infertility, Male","completionDate":"2019-12"},{"nctId":"NCT03863613","phase":"NA","title":"The Effectiveness of Cervical Pessary Compared to Cervical Cerclage With or Without Vaginal Progesterone for the Prevention of Preterm Birth in Women With a Twin Pregnancy and a Short Cervix: a Two-by","status":"TERMINATED","sponsor":"Mỹ Đức Hospital","isPivotal":false,"enrollment":219,"indication":"Preterm Birth, Twin Pregnancy","completionDate":"2023-07-29"},{"nctId":"NCT06979596","phase":"Phase 2","title":"A Multicenter, Open-label, Phase 2 Basket Study of MK-5684 in Participants With Selected Solid Tumors (OMAHA-015)","status":"RECRUITING","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":250,"indication":"Malignant Neoplasm","completionDate":"2027-11-04"},{"nctId":"NCT05737329","phase":"Phase 1","title":"Optimization of Management Tactics for Women With Premature Ovarian Insufficiency, Taking Into Account Their Clinical and Hormonal Profile","status":"UNKNOWN","sponsor":"Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare","isPivotal":false,"enrollment":80,"indication":"Primary Ovarian Insufficiency","completionDate":"2023-04"},{"nctId":"NCT00755963","phase":"Phase 4","title":"The Influence of Hormone Replacement Therapy on the Cerebral Serotonin-1A Receptor Distribution and Mood in Postmenopausal Women","status":"COMPLETED","sponsor":"Medical University of Vienna","isPivotal":false,"enrollment":30,"indication":"Hormone 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(JCM021)","status":"TERMINATED","sponsor":"University of Virginia","isPivotal":false,"enrollment":4,"indication":"Polycystic Ovary Syndrome, Hyperandrogenism","completionDate":"2017-08"},{"nctId":"NCT04453332","phase":"NA","title":"Effects of Oral and Non-oral Hormonal Therapy on Cardiovascular Risk and Body Composition Parameters in Postmenopausal Women","status":"UNKNOWN","sponsor":"Hospital de Clinicas de Porto Alegre","isPivotal":false,"enrollment":60,"indication":"Menopause, Hormone Replacement Therapy","completionDate":"2021-12"},{"nctId":"NCT00694967","phase":"NA","title":"Histologic Evaluation of the Cervix at Risk for Preterm Birth Trial:Medical Versus Surgical Therapy","status":"TERMINATED","sponsor":"Lehigh Valley Hospital","isPivotal":false,"enrollment":92,"indication":"Mid Trimester Cervical Shortening","completionDate":"2006-12"},{"nctId":"NCT00303615","phase":"Phase 2","title":"Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) 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Protocol in Women With Poor Ovarian Response","status":"UNKNOWN","sponsor":"Royan Institute","isPivotal":true,"enrollment":210,"indication":"Infertility","completionDate":"2019-12"},{"nctId":"NCT00003953","phase":"Phase 2","title":"A Phase II Study of Preoperative Dose-Dense Chemotherapy With Sequential Doxorubicin and Docetaxel for Initial Treatment of Operable and Inoperable Stage II-IIIB Breast Cancer","status":"COMPLETED","sponsor":"Case Comprehensive Cancer Center","isPivotal":false,"enrollment":39,"indication":"Breast Cancer","completionDate":"2013-01"},{"nctId":"NCT04460807","phase":"Phase 3","title":"EXemestane in Progesterone and/or Estrogen Receptor Positive Epithelial Ovarian Cancer: A Randomized Phase III Trial, EXPERT","status":"TERMINATED","sponsor":"Ente Ospedaliero Ospedali Galliera","isPivotal":true,"enrollment":23,"indication":"Ovarian Cancer","completionDate":"2023-04-27"},{"nctId":"NCT02937766","phase":"Phase 3","title":"A Phase III, Single-Center, Open-labeled, 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Cycle. A Prospective Study","status":"COMPLETED","sponsor":"ART Fertility Clinics LLC","isPivotal":false,"enrollment":6,"indication":"Infertility, Female","completionDate":"2021-12-30"},{"nctId":"NCT07357922","phase":"N/A","title":"Association Between Maternal Serum Progesterone Levels and Threatened Abortion in Lactating Pregnant Women","status":"NOT_YET_RECRUITING","sponsor":"Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization","isPivotal":false,"enrollment":150,"indication":"Threatened Abortion","completionDate":"2028-01-01"},{"nctId":"NCT02092571","phase":"Phase 1","title":"An Open-Label, Single-Dose, Randomized, 2-Treatment, 2-Period Crossover Pharmacokinetic Study to Evaluate the Bioequivalence of 2 Progesterone Vaginal Rings 20% (w/w) in Postmenopausal Women","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","isPivotal":false,"enrollment":56,"indication":"Pharmacokinetics","completionDate":"2014-08"},{"nctId":"NCT03774745","phase":"Phase 1","title":"A Randomized Trial of Mifepristone Antagonization With High-Dose Progesterone to Prevent Medical Abortion","status":"TERMINATED","sponsor":"University of California, Davis","isPivotal":false,"enrollment":12,"indication":"Pregnancy, Unwanted","completionDate":"2019-08-15"},{"nctId":"NCT02913495","phase":"Phase 4","title":"Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth","status":"COMPLETED","sponsor":"Thomas Jefferson University","isPivotal":false,"enrollment":210,"indication":"Premature Birth","completionDate":"2021-09"},{"nctId":"NCT04722471","phase":"N/A","title":"Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer.","status":"COMPLETED","sponsor":"Instituto Bernabeu","isPivotal":false,"enrollment":347,"indication":"Luteal Phase Defect","completionDate":"2021-03-17"},{"nctId":"NCT00656201","phase":"Phase 4","title":"Comparison of Crinone 8% Intravaginal Gel or Intramuscular Progesterone Supplementation for In Vitro Fertilization (IVF) and Embryo Transfer (ET) Cycles in Women Under Age 40 Years Old","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","isPivotal":false,"enrollment":468,"indication":"Infertility","completionDate":"2009-07"},{"nctId":"NCT00446030","phase":"Phase 2","title":"A Phase II, Open-Label, Multicenter, Pilot Study of the Safety & Efficacy of Two Docetaxel-Based Regimens Plus Bevacizumab for the Adjuvant Treatment of Subjects With Node Positive or High Risk Node N","status":"COMPLETED","sponsor":"Sanofi","isPivotal":false,"enrollment":127,"indication":"Breast Neoplasms","completionDate":"2010-08"},{"nctId":"NCT00073528","phase":"Phase 3","title":"A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor- Positive Advanced or Meta","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","isPivotal":true,"enrollment":1286,"indication":"Breast Neoplasms","completionDate":"2018-03-22"},{"nctId":"NCT05781009","phase":"Phase 2","title":"Pregnenolone for the Treatment of Alcohol Use Disorder","status":"RECRUITING","sponsor":"Yale University","isPivotal":false,"enrollment":150,"indication":"Alcohol Use Disorder","completionDate":"2028-07-31"},{"nctId":"NCT07415070","phase":"NA","title":"Effectiveness of Targeted Cervical Length Screening Guided by a Preterm Birth Risk Scoring System in Reducing the Rate of Preterm Birth: a Cluster Non-randomized Controlled Trial","status":"NOT_YET_RECRUITING","sponsor":"Ningbo University","isPivotal":false,"enrollment":1000,"indication":"Preterm Birth","completionDate":"2027-12"},{"nctId":"NCT02852954","phase":"N/A","title":"Determining Levels of Expression of Progesterone-Induced Blocking Factor in Endometrial Cancer Cells.","status":"COMPLETED","sponsor":"Kayseri Education and Research Hospital","isPivotal":false,"enrollment":60,"indication":"Progesterone Induced Blocking Factor in Endometrial Cancer","completionDate":"2017-03"},{"nctId":"NCT04895358","phase":"Phase 3","title":"A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive,","status":"ACTIVE_NOT_RECRUITING","sponsor":"Merck Sharp & Dohme LLC","isPivotal":true,"enrollment":340,"indication":"Breast Neoplasms","completionDate":"2027-12-18"},{"nctId":"NCT01406197","phase":"NA","title":"Uterine Abdominal Electromyography Measurements Before and After Progesterone Treatments for Preterm Labor","status":"WITHDRAWN","sponsor":"St. Joseph's Hospital and Medical Center, Phoenix","isPivotal":false,"enrollment":0,"indication":"Preterm Labor","completionDate":"2013-10"},{"nctId":"NCT03309176","phase":"Phase 4","title":"Is Endometrial Withdrawal Bleeding Necessary Prior to Ovulation Induction With Clomiphene Citrate? 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