{"id":"prontogest-400-mg-vaginal-pessaries","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Vaginal discharge","drugRate":"10%","severity":"Mild"},{"effect":"Vaginal itching","drugRate":"5%","severity":"Mild"}],"contraindications":["Known hypersensitivity to progesterone"],"specialPopulations":{}},"trials":[],"_chembl":{"chemblId":"CHEMBL5314922","moleculeType":"Small molecule","molecularWeight":"436.52"},"aliases":["placebo vaginal pessaries"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"_dailymed":null,"ecosystem":[],"mechanism":{"target":"Uterine smooth muscle and cervical tissue","novelty":"The vaginal pessary formulation provides a localized delivery method for progesterone, which may offer improved efficacy and reduced systemic side effects compared to oral or injectable forms.","modality":"Vaginal pessary","drugClass":"Progesterone","explanation":"Progesterone is a hormone that plays a crucial role in maintaining pregnancy by reducing uterine contractility and promoting cervical integrity.","oneSentence":"Prontogest 400 mg vaginal pessaries work by delivering progesterone to the vaginal mucosa, which helps maintain uterine quiescence and prevent preterm labor.","technicalDetail":"The vaginal pessary formulation allows for sustained release of progesterone, which is absorbed through the vaginal mucosa and reaches the target tissues in the uterus and cervix."},"_scrapedAt":"2026-03-28T00:02:53.606Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":null,"launchDate":null,"annualCostUS":null,"currentRevenue":null,"patientPopulation":null,"peakSalesEstimate":null},"references":[],"biosimilars":[],"competitors":[],"indications":{"approved":["Prevention of preterm labor"],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT05189145","phase":"NA","title":"Hormonal Monitoring and Progesterone Adjustment in Frozen Embryo Transfer Cycles","status":"COMPLETED","sponsor":"Alexandria University","startDate":"2019-10-01","conditions":"Female Infertility","enrollment":600},{"nctId":"NCT02673359","phase":"PHASE4","title":"Vaginal Progesterone Versus Cervical Cerclage for Pregnant Women With Short Cervix and History of PTL and/or MTM","status":"UNKNOWN","sponsor":"Mohamed Sayed Abdelhafez","startDate":"2016-02","conditions":"Premature Labour","enrollment":220},{"nctId":"NCT04161989","phase":"NA","title":"Omega 3 Plus Vaginal Progesterone on Birth Weight of Constitutionally Small for Gestational Age Fetuses","status":"COMPLETED","sponsor":"Assiut University","startDate":"2020-05-01","conditions":"Small for Gestational Age at Delivery","enrollment":80},{"nctId":"NCT03938064","phase":"PHASE4","title":"Timing of Initiation of Luteal Phase Support in Poor Responders Undergoing IVF/ICSI","status":"UNKNOWN","sponsor":"Ain Shams Maternity Hospital","startDate":"2019-06-26","conditions":"Infertility","enrollment":520},{"nctId":"NCT03633175","phase":"PHASE2","title":"Progesterone in Patients With Placenta Previa","status":"UNKNOWN","sponsor":"Ain Shams University","startDate":"2018-07-05","conditions":"Placenta Previa","enrollment":74},{"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":"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}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Gastroenterology"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Prontogest 400 mg vaginal pessaries","genericName":"Prontogest 400 mg vaginal pessaries","companyName":"Ain Shams Maternity Hospital","companyId":"ain-shams-maternity-hospital","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Prontogest 400 mg vaginal pessaries are a progesterone-based medication used primarily for the prevention of preterm labor. The drug is manufactured by Ain Shams Maternity Hospital and is not approved by the FDA. It works by maintaining uterine quiescence and preventing premature cervical ripening. While it is primarily used for its approved indication, there are no specific FDA-approved labels or detailed clinical trial data available. The safety profile includes common side effects such as vaginal discharge and itching, and it is contraindicated in women with known hypersensitivity to progesterone. The drug is not commercially available in the United States, and there is limited information on its revenue and market performance.","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}