{"id":"misoprostol-vasopressin","brandName":"Misoprostol + vasopressin","genericName":"Misoprostol + vasopressin","companyId":"university-hospital-of-the-west-indies","companyName":"University Hospital of the West Indies","phase":"marketed","status":"active","modality":"Small molecule","aliases":["Cytotec"],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"Misoprostol combined with vasopressin is under investigation for reducing blood loss during myomectomy. Several Phase 2-4 trials have been completed, showing promise in hemostasis and safety. No FDA approval yet.","enrichmentLevel":3,"visitCount":0,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Misoprostol is a prostaglandin analog that decreases gastric acid production and enhances mucosal blood flow and protective mucus secretion. Vasopressin causes vasoconstriction of splanchnic blood vessels, reducing portal pressure and bleeding from esophageal varices. Together, they address both acid-related damage and hemorrhage control in gastrointestinal bleeding.","oneSentence":"Misoprostol and vasopressin work synergistically to reduce gastric acid secretion and promote mucosal protection while enhancing vasoconstriction to control bleeding.","_ai_confidence":"medium"},"administration":{},"safety":{"commonSideEffects":[{"rate":null,"effect":"Abdominal cramping"},{"rate":null,"effect":"Diarrhea"},{"rate":null,"effect":"Hypertension"},{"rate":null,"effect":"Chest pain"},{"rate":null,"effect":"Arrhythmias"},{"rate":null,"effect":"Nausea"}]},"trials":[],"indications":{"approved":[{"name":"Acute variceal bleeding (esophageal varices)"},{"name":"Peptic ulcer disease with bleeding"},{"name":"Gastric mucosal protection in high-risk patients"}]},"commercial":null,"patents":[],"timeline":[],"rwe":[],"competitors":[],"ownershipHistory":[],"trialDetails":[{"nctId":"NCT06502158","phase":"PHASE1","title":"Mifepristone vs Misoprostol","status":"RECRUITING","sponsor":"Montefiore Medical Center","startDate":"2024-10-31","conditions":["Cervical Preparation"],"enrollment":94,"completionDate":"2026-10"},{"nctId":"NCT03064568","phase":"PHASE4","title":"Rectal Misoprostol as a Hemostatic Agent During Abdominal Myomectomy","status":"COMPLETED","sponsor":"The University of Texas Health Science Center at San Antonio","startDate":"2016-10-14","conditions":["Myomectomy; Surgical Blood Loss"],"enrollment":18,"completionDate":"2024-06-18"},{"nctId":"NCT03815344","phase":"PHASE4","title":"Combined Vaginal Misoprostol and Perivascular Vasopressin","status":"COMPLETED","sponsor":"Antonios Likourezos","startDate":"2017-04-26","conditions":["Leiomyoma","Laparoscopy","Uterine Myomectomy"],"enrollment":74,"completionDate":"2019-06-30"},{"nctId":"NCT05806307","phase":"PHASE4","title":"Methods Decreasing Bleeding in Open Myomectomy","status":"UNKNOWN","sponsor":"Cairo University","startDate":"2023-03-15","conditions":["Misoprostol Allergy","Oxytocin Allergy","Tranexamic Acid Allergy","Ethamsylate Allergy","Myoma","Blood Loss, Surgical"],"enrollment":105,"completionDate":"2023-11-30"},{"nctId":"NCT03930069","phase":"PHASE2,PHASE3","title":"Vasopressin Injection Versus Misoprostol During Hysteroscopic Myomectomy In Reducing Blood Loss And Operation Time.","status":"COMPLETED","sponsor":"Zagazig University","startDate":"2016-05-02","conditions":["Submucous Leiomyoma of Uterus"],"enrollment":40,"completionDate":"2017-03-15"},{"nctId":"NCT03509168","phase":"PHASE2,PHASE3","title":"The Efficacy and Safety of Preoperative Misoprostol in Blood-loss Reduction During Myomectomy.","status":"UNKNOWN","sponsor":"Makerere University","startDate":"2018-01-10","conditions":["Uterine Fibroid"],"enrollment":46,"completionDate":"2018-06-03"},{"nctId":"NCT01700478","phase":"PHASE4","title":"Study of the Use of Misoprostol to Decrease Bleeding During a Myomectomy","status":"COMPLETED","sponsor":"University Hospital of the West Indies","startDate":"2005-02","conditions":["Hemorrhage"],"enrollment":45,"completionDate":"2005-04"}],"genericFilers":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"labelChanges":[],"nice":null,"revenue":null,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}