{"id":"prostaglandin-e2-prostin","safety":{"commonSideEffects":[{"rate":null,"effect":"Uterine contractions/cramping"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fever"},{"rate":null,"effect":"Vomiting"},{"rate":null,"effect":"Abdominal pain"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"PGE2 is an endogenous eicosanoid that acts as a signaling molecule through four G-protein coupled receptors (EP1-EP4). Depending on the receptor subtype and tissue context, PGE2 can promote vasodilation, inhibit platelet aggregation, enhance mucus secretion, and modulate immune responses. In clinical use, exogenous PGE2 is employed to induce labor, maintain patent ductus arteriosus in neonates, and protect gastric mucosa.","oneSentence":"Prostaglandin E2 (PGE2) binds to prostaglandin E receptors (EP receptors) on cell surfaces to modulate inflammation, vasodilation, and smooth muscle contraction.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:03:11.840Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Labor induction"},{"name":"Maintenance of patent ductus arteriosus in neonates"},{"name":"Gastric ulcer prevention and treatment"}]},"trialDetails":[{"nctId":"NCT03471858","phase":"NA","title":"Mechanical Dilation of the Cervix in a Scarred Uterus","status":"COMPLETED","sponsor":"Ministry of Health, Singapore","startDate":"2019-08-29","conditions":"Pregnancy Related, Labor Complication, Cesarean Section; Dehiscence","enrollment":44},{"nctId":"NCT00545194","phase":"PHASE3","title":"Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess","status":"WITHDRAWN","sponsor":"Institut National de la Santé Et de la Recherche Médicale, France","startDate":"2002-01","conditions":"Cervical Ripening, Labor, Induced","enrollment":""},{"nctId":"NCT02956785","phase":"PHASE2","title":"What After the First Propess","status":"TERMINATED","sponsor":"South Warwickshire NHS Foundation Trust","startDate":"2017-01","conditions":"Induction of Labor","enrollment":85},{"nctId":"NCT04500496","phase":"NA","title":"Vaginal Dinoprostone Versus Isonicotinic Acid Hydrazide Prior to Diagnostic Office Hysteroscopy","status":"UNKNOWN","sponsor":"Aswan University Hospital","startDate":"2020-09-01","conditions":"Postmenopausal Bleeding","enrollment":200},{"nctId":"NCT04743297","phase":"PHASE4","title":"Propess Versus Prostin for Induction of Labour in Women With Term PROM","status":"UNKNOWN","sponsor":"University Medical Centre Maribor","startDate":"2021-03","conditions":"Premature Rupture of Membranes at Term, Induction of Labour","enrollment":526},{"nctId":"NCT04044079","phase":"PHASE4","title":"Vaginal Dinoprostone Versus Vaginal Misoprostol Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients","status":"COMPLETED","sponsor":"Cairo University","startDate":"2019-08-20","conditions":"Office Hysteroscopy","enrollment":150},{"nctId":"NCT04505943","phase":"NA","title":"Vaginal Misoprostol and Dinoprostone and Isonicotinic Acid Hydrazide Prior to Copper Intrauterine Device Insertion","status":"UNKNOWN","sponsor":"Aswan University Hospital","startDate":"2020-09-01","conditions":"IUCD Complication","enrollment":200},{"nctId":"NCT04505917","phase":"NA","title":"Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Women","status":"UNKNOWN","sponsor":"Aswan University Hospital","startDate":"2020-09-01","conditions":"IUCD Complication","enrollment":200},{"nctId":"NCT04079140","phase":"PHASE4","title":"Vaginal Dinoprostone Administration Prior to Intrauterine Device Insertion","status":"COMPLETED","sponsor":"Cairo University","startDate":"2019-09-15","conditions":"IUD Insertion Pain","enrollment":130},{"nctId":"NCT04280874","phase":"PHASE4","title":"Induction of Labor in Term Pregnancies With Unfavourable Cervix","status":"COMPLETED","sponsor":"Clinical Hospital Merkur","startDate":"2018-12-10","conditions":"Induction of Labor Affected Fetus / Newborn, Prostaglandins Causing Adverse Effects in Therapeutic Use","enrollment":212},{"nctId":"NCT03686085","phase":"PHASE3","title":"Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.","status":"COMPLETED","sponsor":"Cairo University","startDate":"2018-09-30","conditions":"Intrauterine Device","enrollment":200},{"nctId":"NCT04080336","phase":"PHASE4","title":"Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Nulliparous Women","status":"COMPLETED","sponsor":"Cairo 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Pain","enrollment":300},{"nctId":"NCT04042974","phase":"PHASE4","title":"Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Primarily Infertile Patients","status":"UNKNOWN","sponsor":"Cairo University","startDate":"2019-08-10","conditions":"Hysteroscopy","enrollment":100},{"nctId":"NCT03199820","phase":"PHASE4","title":"Balloon Catheter Versus Propess for Labour Induction","status":"UNKNOWN","sponsor":"St George's, University of London","startDate":"2017-09-22","conditions":"Childbirth Problems, Labor Complication","enrollment":120},{"nctId":"NCT02993432","phase":"NA","title":"High Volume Foleys Increasing Vaginal Birth Pilot Trial","status":"UNKNOWN","sponsor":"Sunnybrook Health Sciences Centre","startDate":"2016-12","conditions":"Labour; Induced, Pilot Study, Cervical Ripening","enrollment":130},{"nctId":"NCT03683914","phase":"PHASE4","title":"Vaginal Dinoprostone Prior to Diagnostic Office Hysteroscopy in Postmenopausal Patients","status":"COMPLETED","sponsor":"Cairo University","startDate":"2018-09-30","conditions":"Office Hysteroscopy","enrollment":102},{"nctId":"NCT02620215","phase":"PHASE4","title":"Cervical Ripening Balloon in Induction of Labour at Term","status":"COMPLETED","sponsor":"KK Women's and Children's Hospital","startDate":"2015-11","conditions":"Pregnancy","enrollment":417},{"nctId":"NCT03489928","phase":"PHASE3","title":"Misoprostol Labour Induction Study","status":"COMPLETED","sponsor":"David Young","startDate":"1999-04-01","conditions":"Induction of Labour, Labour, Induced","enrollment":511},{"nctId":"NCT02486679","phase":"PHASE4","title":"A Trial of Prostaglandin E2 Tablets Versus Foley Catheter for Labor Induction","status":"UNKNOWN","sponsor":"Wolfson Medical Center","startDate":"2015-07","conditions":"Labor, Induced","enrollment":300},{"nctId":"NCT01635439","phase":"PHASE3","title":"Prostin and Propess in Induction of Labor","status":"COMPLETED","sponsor":"Ain Shams University","startDate":"2010-12","conditions":"Labor Pain","enrollment":200},{"nctId":"NCT01384812","phase":"NA","title":"Prostaglandin E2 in Migraine Suffers Without Aura.","status":"COMPLETED","sponsor":"Troels Wienecke","startDate":"2010-09","conditions":"\"Migraine-like\" Headache","enrollment":12}],"_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":["dinoprostone"],"phase":"marketed","status":"active","brandName":"Prostaglandin E2 (Prostin)","genericName":"Prostaglandin E2 (Prostin)","companyName":"University Medical Centre Maribor","companyId":"university-medical-centre-maribor","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Prostaglandin E2, also known as Prostin, is a small molecule that has been studied for its use in various obstetric conditions, including IUD insertion pain, induction of labor, and premature rupture of membranes at term. It is administered via vaginal dinoprostone, which is used to ripen the cervix and facilitate these procedures.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1995-03-30T00:00:00.000Z","mah":"FERRING PHARMS INC","brand_name_local":"CERVIDIL","application_number":"NDA020411"}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}