{"id":"clotrimazole-vaginal-ovule","safety":{"commonSideEffects":[{"rate":null,"effect":"Vulvovaginal irritation"},{"rate":null,"effect":"Burning sensation"},{"rate":null,"effect":"Vaginal discharge"},{"rate":null,"effect":"Abdominal cramping"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Clotrimazole is an imidazole antifungal that inhibits the fungal cytochrome P450 enzyme lanosterol 14α-demethylase, blocking the conversion of lanosterol to ergosterol. This disrupts the structural integrity of the fungal cell membrane, causing leakage of cellular contents and fungal cell death. The vaginal ovule formulation delivers the drug directly to the site of infection.","oneSentence":"Clotrimazole disrupts fungal cell membrane integrity by inhibiting ergosterol synthesis, leading to cell death.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:06:28.233Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Vulvovaginal candidiasis"}]},"trialDetails":[{"nctId":"NCT06349122","phase":"PHASE4","title":"Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth","status":"NOT_YET_RECRUITING","sponsor":"Assistance Publique Hopitaux De Marseille","startDate":"2024-08","conditions":"Bacterial Vaginosis, Vaginal Dysbiosis, Premature Delivery","enrollment":1292},{"nctId":"NCT00755053","phase":"PHASE3","title":"Comparative Efficacy of Ovule vs Tablet","status":"COMPLETED","sponsor":"Bayer","startDate":"2008-09","conditions":"Clotrimazole, Ovulen, Vulvovaginal Candidiasis","enrollment":466},{"nctId":"NCT00194324","phase":"PHASE4","title":"Effect of Exercise on Spread of the Miconozole Nitrate OVULE in the Vagina","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2004-07","conditions":"Health, Vulvovaginal Candidiasis","enrollment":12}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":2,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Clotrimazole, vaginal ovule","genericName":"Clotrimazole, vaginal ovule","companyName":"Bayer","companyId":"bayer","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Clotrimazole disrupts fungal cell membrane integrity by inhibiting ergosterol synthesis, leading to cell death. Used for Vulvovaginal candidiasis.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}