{"id":"progesterone-vaginal-product","safety":{"commonSideEffects":[{"rate":null,"effect":"Vaginal irritation or discharge"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Breast tenderness"},{"rate":null,"effect":"Abdominal discomfort"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Progesterone is a naturally occurring steroid hormone that acts as a ligand for progesterone receptors (PR-A and PR-B) in endometrial and vaginal tissues. When administered vaginally, it provides local and systemic progesterone supplementation to support endometrial secretion, reduce uterine contractility, and maintain pregnancy in the luteal phase. This is particularly important in assisted reproductive technology (ART) and in patients with luteal phase deficiency.","oneSentence":"Progesterone binds to progesterone receptors in the reproductive tract to support luteal phase function and maintain pregnancy.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:02:50.874Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Luteal phase support in assisted reproductive technology (ART)"},{"name":"Pregnancy maintenance in women with progesterone deficiency"}]},"trialDetails":[{"nctId":"NCT07136922","phase":"PHASE1","title":"First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency","status":"NOT_YET_RECRUITING","sponsor":"Calla Lily Clinical Care Ltd","startDate":"2026-04","conditions":"Luteal Phase Insuffiency, Progesterone Delivery","enrollment":20},{"nctId":"NCT04872660","phase":"PHASE4","title":"Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing IVF-ET","status":"RECRUITING","sponsor":"Shandong University of Traditional Chinese Medicine","startDate":"2021-06-15","conditions":"Infertility, Female","enrollment":800},{"nctId":"NCT07264933","phase":"NA","title":"Postplacental Copper Intrauterine Device Versus Postpartum Progesterone-only Pills on Uterine Niche Formation","status":"COMPLETED","sponsor":"Benha University","startDate":"2025-02-12","conditions":"Scar Niche, Myometrial Remodeling, Contraceptive Device; Complications","enrollment":750},{"nctId":"NCT05080569","phase":"PHASE4","title":"Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment","status":"RECRUITING","sponsor":"UMC Utrecht","startDate":"2023-03-01","conditions":"Pregnancy Related, Fertility Issues, Luteal Phase Defect","enrollment":1008},{"nctId":"NCT06463652","phase":"NA","title":"Cerclage With Progesterone Versus Progesterone Only in Singleton Pregnancies","status":"RECRUITING","sponsor":"Mỹ Đức Hospital","startDate":"2024-06-26","conditions":"Preterm Birth, Short Cervix","enrollment":328},{"nctId":"NCT04833140","phase":"PHASE3","title":"Estrogen Administration for the Treatment of NASH in Postmenopausal Women","status":"RECRUITING","sponsor":"Massachusetts General Hospital","startDate":"2021-12-02","conditions":"NASH - Nonalcoholic Steatohepatitis","enrollment":60},{"nctId":"NCT07097246","phase":"","title":"A Study on the Correlation of Drug Metabolism and Human Body Composition Based on the Bioequivalence Trial of Progesterone Sustained-release Vaginal Gel","status":"COMPLETED","sponsor":"Second Affiliated Hospital of Wenzhou Medical University","startDate":"2024-06-25","conditions":"Healthy","enrollment":48},{"nctId":"NCT07003373","phase":"NA","title":"Comparison of Two Protocols in Frozen Embryo Transfer","status":"NOT_YET_RECRUITING","sponsor":"Malihe Mahmoudinia","startDate":"2025-07-05","conditions":"IVF Outcomes","enrollment":112},{"nctId":"NCT05255653","phase":"PHASE2, PHASE3","title":"Refining Adjuvant Treatment in Endometrial Cancer Based on Molecular Features","status":"RECRUITING","sponsor":"Leiden University Medical Center","startDate":"2021-11-11","conditions":"Endometrial Cancer","enrollment":1615},{"nctId":"NCT03701490","phase":"PHASE2","title":"Prolutex in Frozen Embryo Transfer Cycles At the Blastocyst Stage (PROGEX)","status":"COMPLETED","sponsor":"IBSA Institut Biochimique SA","startDate":"2019-03-12","conditions":"Infertility","enrollment":213},{"nctId":"NCT04725864","phase":"PHASE4","title":"Progesterone as Luteal Support in Frozen IVF Natural Cycles","status":"RECRUITING","sponsor":"Vastra Gotaland Region","startDate":"2021-05-01","conditions":"Infertility, Embryo Transfer","enrollment":1800},{"nctId":"NCT02460302","phase":"PHASE2","title":"Vaginal Progesterone Versus Placebo for the Treatment of Vaginal Atrophy","status":"WITHDRAWN","sponsor":"Mount Sinai Hospital, Canada","startDate":"2016-12","conditions":"Atrophic Vaginitis, Menopause, Vulvovaginal Atrophy","enrollment":""},{"nctId":"NCT03863613","phase":"NA","title":"Pessary Versus Cerclage With or Without Progesterone in Twins","status":"TERMINATED","sponsor":"Mỹ Đức Hospital","startDate":"2019-03-23","conditions":"Preterm Birth, Twin Pregnancy, Short Cervix","enrollment":219},{"nctId":"NCT01406197","phase":"NA","title":"Uterine Electrical Activity Before and After Progesterone Treatment for Preterm Labor","status":"WITHDRAWN","sponsor":"St. Joseph's Hospital and Medical Center, Phoenix","startDate":"2011-07","conditions":"Preterm Labor","enrollment":""},{"nctId":"NCT05308342","phase":"NA","title":"Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Premature Ovarian Insufficiency","status":"UNKNOWN","sponsor":"Li-jun Ding","startDate":"2019-11-20","conditions":"Premature Ovarian Insufficiency","enrollment":66},{"nctId":"NCT04537078","phase":"PHASE3","title":"Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders","status":"COMPLETED","sponsor":"El Shatby University Hospital for Obstetrics and Gynecology","startDate":"2020-09-01","conditions":"Infertility, Female","enrollment":90},{"nctId":"NCT04769401","phase":"NA","title":"Effects of E2, P4 and LH Levels on the Day of Transfer and Endometrial Cavity Thickness on Implantation Success in Patients With Frozen-thawed Embryo Transfer Cycle","status":"COMPLETED","sponsor":"Bezmialem Vakif University","startDate":"2021-02-01","conditions":"Infertility, IVF, Progesterone","enrollment":238},{"nctId":"NCT05062135","phase":"NA","title":"Progesterone Action on Endometrium of PCOS","status":"COMPLETED","sponsor":"University of Sao Paulo General Hospital","startDate":"2014-02-10","conditions":"Polycystic Ovary, Progesterone Resistance","enrollment":36},{"nctId":"NCT05189873","phase":"PHASE3","title":"GnRH Agonist Plus Hormone Replacement Therapy vs Hormone Replacement Therapy on IVF Outcomes","status":"COMPLETED","sponsor":"Tehran University of Medical Sciences","startDate":"2021-06-10","conditions":"Polycystic Ovary Syndrome, Infertility, Female","enrollment":128},{"nctId":"NCT04797338","phase":"PHASE4","title":"Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders","status":"UNKNOWN","sponsor":"Assaf-Harofeh Medical Center","startDate":"2017-12-29","conditions":"Pregnancy Early, Miscarriage, Ovarian Hyperstimulation Syndrome","enrollment":100},{"nctId":"NCT02620904","phase":"PHASE4","title":"Mifepristone Induction for Fetal Demise","status":"TERMINATED","sponsor":"Montefiore Medical Center","startDate":"2016-07-14","conditions":"Intrauterine Fetal Demise, Fetal Death","enrollment":9},{"nctId":"NCT03181685","phase":"PHASE4","title":"Patients' Preference for Subcutaneous or Vaginal Progesterone as Luteal Support in IVF/ICSI Cycles","status":"TERMINATED","sponsor":"Andros Day Surgery Clinic","startDate":"2016-12-20","conditions":"Infertility, In Vitro Fertilization","enrollment":60},{"nctId":"NCT03709849","phase":"PHASE2","title":"Effectiveness and Safety of Bushen Culuan Decoction for Anovulatory Infertility","status":"UNKNOWN","sponsor":"Xiyuan Hospital of China Academy of Chinese Medical Sciences","startDate":"2019-02-01","conditions":"Anovulatory Infertility, Abnormal Uterine Bleeding-Ovulatory Disorders, Polycystic Ovarian Syndrome","enrollment":528},{"nctId":"NCT02798653","phase":"PHASE3","title":"Evaluation of Different Luteal Phase Support Methods in Patients With Poor Ovarian Response","status":"UNKNOWN","sponsor":"Royan Institute","startDate":"2015-11","conditions":"Infertility","enrollment":210},{"nctId":"NCT03540979","phase":"NA","title":"Endometrial Preparation in Frozen Embryo Transfer Cycles","status":"UNKNOWN","sponsor":"Meir Medical Center","startDate":"2018-06","conditions":"Reproductive Behavior","enrollment":100},{"nctId":"NCT03267771","phase":"PHASE4","title":"Progesterone and Doppler in Recurrent Abortion","status":"UNKNOWN","sponsor":"Assiut University","startDate":"2017-10-01","conditions":"Abortion in First Trimester","enrollment":50},{"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":"NCT02350231","phase":"PHASE2, PHASE3","title":"Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth","status":"COMPLETED","sponsor":"Assiut University","startDate":"2014-02-01","conditions":"Preterm Birth","enrollment":100},{"nctId":"NCT02601898","phase":"PHASE4","title":"Vaginal Administration of ALA vs Progesterone for the Subchorionic Hematoma Treatment","status":"COMPLETED","sponsor":"Azienda USL Ferrara","startDate":"2015-01","conditions":"Subchorionic Hematoma in the First Trimester Pregnancy, Miscarriage","enrollment":54},{"nctId":"NCT02114645","phase":"NA","title":"The Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes","status":"UNKNOWN","sponsor":"Zekai Tahir Burak Women's Health Research and Education Hospital","startDate":"2014-04","conditions":"Infertility","enrollment":100},{"nctId":"NCT01178931","phase":"NA","title":"Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support","status":"COMPLETED","sponsor":"University of Zagreb","startDate":"2010-10","conditions":"Luteal Phase Defect","enrollment":853},{"nctId":"NCT01206998","phase":"NA","title":"Vaginal Progesterone as a Treatment for Women Active Preterm Labor","status":"WITHDRAWN","sponsor":"University of Rochester","startDate":"2010-07","conditions":"Labor, Premature","enrollment":""},{"nctId":"NCT01367912","phase":"NA","title":"Timing of Estrogen Support During the Luteal Phase of in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Cycle","status":"COMPLETED","sponsor":"Zekai Tahir Burak Women's Health Research and Education Hospital","startDate":"2008-02","conditions":"Infertility","enrollment":301},{"nctId":"NCT00919919","phase":"PHASE2","title":"Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen","status":"UNKNOWN","sponsor":"Rabin Medical Center","startDate":"2009-06","conditions":"Endometrial Hyperplasia, Endometrial Cancer","enrollment":60},{"nctId":"NCT00732693","phase":"PHASE4","title":"Evaluation of Physiologic and Standard Sex Steroid Replacement Regimens in Women With Premature Ovarian Failure","status":"COMPLETED","sponsor":"University of Edinburgh","startDate":"2002-02","conditions":"Premature Ovarian Failure","enrollment":42}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Utrogestan"],"phase":"marketed","status":"active","brandName":"Progesterone Vaginal Product","genericName":"Progesterone Vaginal Product","companyName":"UMC Utrecht","companyId":"umc-utrecht","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Progesterone binds to progesterone receptors in the reproductive tract to support luteal phase function and maintain pregnancy. Used for Luteal phase support in assisted reproductive technology (ART), Pregnancy maintenance in women with progesterone deficiency.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}