{"id":"crinone8","safety":{"commonSideEffects":[{"rate":null,"effect":"Vaginal discharge or irritation"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Breast tenderness"},{"rate":null,"effect":"Abdominal pain or cramping"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Crinone provides sustained-release progesterone via a bioadhesive vaginal gel formulation, allowing local delivery to the endometrium and systemic absorption. This supports endometrial proliferation and secretion necessary for embryo implantation and early pregnancy maintenance, particularly in assisted reproductive technology (ART) cycles and luteal phase support.","oneSentence":"Crinone is a progesterone vaginal gel that delivers micronized progesterone directly to the reproductive tract to support luteal phase function and early pregnancy.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:07:52.515Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Luteal phase support in assisted reproductive technology (ART) cycles"},{"name":"Progesterone replacement therapy in women with progesterone deficiency"}]},"trialDetails":[{"nctId":"NCT04549116","phase":"PHASE3","title":"Subcutaneous Progesterone in Frozen- Thawed Single Euploid Blastocyst Transfer.","status":"ACTIVE_NOT_RECRUITING","sponsor":"IBSA Institut Biochimique SA","startDate":"2022-10-12","conditions":"Infertility","enrollment":680},{"nctId":"NCT04719000","phase":"PHASE4","title":"PErsonalized Addition of Recombinant LH in Ovarian Stimulation","status":"RECRUITING","sponsor":"Fundación Santiago Dexeus Font","startDate":"2021-02-04","conditions":"Infertility","enrollment":120},{"nctId":"NCT03858049","phase":"PHASE4","title":"Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)","status":"TERMINATED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2019-05-31","conditions":"Infertility","enrollment":172},{"nctId":"NCT02133573","phase":"PHASE2","title":"Randomized Trial of Maternal Progesterone Therapy","status":"COMPLETED","sponsor":"Children's Hospital of Philadelphia","startDate":"2014-07","conditions":"Congenital Heart Disease, Periventricular Leucomalacia, Brain Development","enrollment":102},{"nctId":"NCT01959464","phase":"PHASE4","title":"Sexual Absorption of Vaginal Progesterone","status":"COMPLETED","sponsor":"Wake Forest University Health Sciences","startDate":"2008-11","conditions":"Infertility, Pregnancy","enrollment":20},{"nctId":"NCT01599494","phase":"PHASE3","title":"An Efficacy and Safety Study of Corifollitropin Alfa (MK-8962) in Contrast to Recombinant FSH for Use in Controlled Ovarian Stimulation of Indian Women (P07056, Also Known as MK-8962-029)","status":"WITHDRAWN","sponsor":"Organon and Co","startDate":"2014-03","conditions":"Infertility","enrollment":""},{"nctId":"NCT03948022","phase":"PHASE4","title":"Luteal Support in Frozen-Thawed Embryo Transfer Cycles","status":"COMPLETED","sponsor":"Centrum Clinic IVF Center","startDate":"2021-06-30","conditions":"Implantation; Placenta, Pregnancy Loss, Frozen Embryo","enrollment":151},{"nctId":"NCT04124913","phase":"PHASE4","title":"Oral Dydrogesterone vs. Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles","status":"UNKNOWN","sponsor":"Memorial Sisli Hospital, Istanbul","startDate":"2019-01-02","conditions":"Infertility, Female, Infertility, Male, Embryo Transfer","enrollment":140},{"nctId":"NCT02491437","phase":"PHASE3","title":"A Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II)","status":"COMPLETED","sponsor":"Abbott","startDate":"2015-07","conditions":"Female Infertility","enrollment":1034},{"nctId":"NCT02772120","phase":"PHASE4","title":"Comparison of Vaginal and Intramuscular Progesterone in Vitrified-warmed Blastocyst Transfer Cycles","status":"WITHDRAWN","sponsor":"Brigham and Women's Hospital","startDate":"","conditions":"Infertility","enrollment":""},{"nctId":"NCT03440359","phase":"PHASE2, PHASE3","title":"Vaginal Progesterone Supplementation in Women With PCOS Undergoing Ovulation Induction With Letrozole","status":"COMPLETED","sponsor":"Eastern Virginia Medical School","startDate":"2012-07-06","conditions":"Polycystic Ovary Syndrome","enrollment":52},{"nctId":"NCT02316626","phase":"PHASE4","title":"Subcutaneous Progesterone Versus Vaginal Progesterone Gel for Luteal Phase Support","status":"COMPLETED","sponsor":"Roberta Venturella","startDate":"2014-12","conditions":"Infertility","enrollment":246},{"nctId":"NCT02793908","phase":"PHASE3","title":"Subcutaneous Progesterone Supplementation in Patients With Endometriosis","status":"UNKNOWN","sponsor":"University Magna Graecia","startDate":"2016-06","conditions":"Endometriosis","enrollment":52},{"nctId":"NCT02048891","phase":"PHASE4","title":"Ovulation Trigger With hCG Compared to GnRH Agonist in Patients With Repeated IVF Failures","status":"COMPLETED","sponsor":"Rambam Health Care Campus","startDate":"2014-10","conditions":"Infertility","enrollment":3},{"nctId":"NCT01081652","phase":"PHASE3","title":"A Study Using Micronised Progesterone (Crinone® 8%) in the Luteal Phase Support of Women Undergoing in Vitro Fertilisation (IVF) and Embryo Transfer (ET)","status":"COMPLETED","sponsor":"Merck KGaA, Darmstadt, Germany","startDate":"2004-05","conditions":"Infertility","enrollment":238},{"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":"NCT00615251","phase":"PHASE3","title":"A Clinical Trial to Evaluate the Efficacy and Safety of DR-2011 for In Vitro Fertilization","status":"COMPLETED","sponsor":"Duramed Research","startDate":"2008-02","conditions":"Infertility","enrollment":1297},{"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":"NCT01057511","phase":"PHASE1, PHASE2","title":"Compare the Difference of P4 Concentration in Serum and Endometrium After Vaginal and IM P Administration","status":"COMPLETED","sponsor":"Peking Union Medical College Hospital","startDate":"2009-12","conditions":"Postmenopausal Endometrium","enrollment":51},{"nctId":"NCT00656201","phase":"PHASE4","title":"Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2003-07","conditions":"Infertility","enrollment":468},{"nctId":"NCT00296478","phase":"PHASE3","title":"Multi-Center, Randomized, Open-Label, Parallel Group Study of a Vaginal Micronized Progesterone Tablet (Endometrin®) Compared to Crinone 8% Vaginal Gel in Female Patients Undergoing In-Vitro Fertilization (IVF)","status":"COMPLETED","sponsor":"Ferring Pharmaceuticals","startDate":"2005-07","conditions":"Fertility","enrollment":1211},{"nctId":"NCT01237535","phase":"PHASE4","title":"Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates","status":"UNKNOWN","sponsor":"Rabin Medical Center","startDate":"2011-11","conditions":"Unexplained Infertility, Mild Male Factor","enrollment":400},{"nctId":"NCT00750451","phase":"NA","title":"Low Molecular Weight Heparin in Recurrent Implantation Failure","status":"COMPLETED","sponsor":"V.K.V. American Hospital, Istanbul","startDate":"2006-01","conditions":"Infertility, Fertilization in Vitro, Recurrent Implantation Failure","enrollment":""},{"nctId":"NCT00708539","phase":"PHASE4","title":"A Prospective Randomized Multicentre Study to Compare Crinone 8% Once Daily Versus Other Vaginal Progesterone.","status":"UNKNOWN","sponsor":"Nordica Fertility Clinic","startDate":"2006-04","conditions":"IVF - Luteal Phase Support After Embryo Transfer","enrollment":2686}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["vaginal progesterone"],"phase":"phase_3","status":"active","brandName":"Crinone8","genericName":"Crinone8","companyName":"University Magna Graecia","companyId":"university-magna-graecia","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Crinone is a progesterone vaginal gel that delivers micronized progesterone directly to the reproductive tract to support luteal phase function and early pregnancy. Used for Luteal phase support in assisted reproductive technology (ART) cycles, Progesterone replacement therapy in women with progesterone deficiency.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}