{"id":"placebo-ovules","safety":{"commonSideEffects":[]},"_chembl":{"chemblId":"CHEMBL2103735","moleculeType":"Protein","molecularWeight":"1491.12"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Placebo ovules are formulated vaginal dosage forms containing no active drug substance. They are used in clinical trials as control comparators to measure the placebo effect and distinguish true drug efficacy from patient expectation and natural disease progression. The therapeutic response observed is attributed to psychological and psychosomatic mechanisms rather than pharmacological action.","oneSentence":"Placebo ovules contain inert ingredients with no active pharmaceutical component and produce therapeutic effects primarily through the placebo effect.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:28:17.937Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Clinical trial control comparator (indication-dependent on parent trial)"}]},"trialDetails":[{"nctId":"NCT04982692","phase":"PHASE3","title":"A Clinical Study of INTRAROSA® (Prasterone) Vaginal Inserts in Postmenopausal Vulvovaginal Atrophy","status":"COMPLETED","sponsor":"Lee's Pharmaceutical Limited","startDate":"2021-09-13","conditions":"Postmenopausal Vulvovaginal Atrophy","enrollment":417},{"nctId":"NCT05311020","phase":"NA","title":"Efficacy Evaluation of Pitaya Ovule Extract on Skin","status":"COMPLETED","sponsor":"TCI Co., Ltd.","startDate":"2022-10-19","conditions":"Skin Condition","enrollment":50},{"nctId":"NCT05649735","phase":"NA","title":"EFFICACY AND SAFETY OF OVA AND LAVAGE MEDICAL DEVICES IN THE TREATMENT OF NON-SPECIFIC VULVOVAGINITIS","status":"COMPLETED","sponsor":"Ospedale del Mare","startDate":"2020-07-17","conditions":"Vaginosis, Bacterial","enrollment":91},{"nctId":"NCT04898556","phase":"PHASE3","title":"Clinical Study to Evaluate the Efficacy of Prasterone Treatment for Atrophy Vulvovaginal in Postmenopausal Women With Vulvar / Vestibular Pain","status":"UNKNOWN","sponsor":"Dr. Santiago Palacios","startDate":"2020-12-22","conditions":"Vulvovaginal Atrophy","enrollment":50},{"nctId":"NCT03740945","phase":"PHASE3","title":"Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer","status":"WITHDRAWN","sponsor":"EndoCeutics Inc.","startDate":"2018-11-06","conditions":"Vaginal Atrophy in Breast Cancer Patients","enrollment":""},{"nctId":"NCT03917134","phase":"NA","title":"Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy","status":"UNKNOWN","sponsor":"CES University","startDate":"2019-05-01","conditions":"Hysterectomy, Cellulitis, Vaginosis","enrollment":600},{"nctId":"NCT02013544","phase":"PHASE3","title":"Intravaginal Prasterone (DHEA) Against Vulvovaginal Atrophy Associated With Menopause","status":"COMPLETED","sponsor":"EndoCeutics Inc.","startDate":"2014-02","conditions":"Vaginal Atrophy","enrollment":558},{"nctId":"NCT01031017","phase":"PHASE4","title":"Prophylactic Administration of Natural Progesterone in the Prevention of Preterm Delivery in Twin Pregnancies","status":"COMPLETED","sponsor":"University of Sao Paulo","startDate":"2007-06","conditions":"Preterm Delivery","enrollment":390}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":13,"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":"Placebo ovules","genericName":"Placebo ovules","companyName":"Lee's Pharmaceutical Limited","companyId":"lee-s-pharmaceutical-limited","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Placebo ovules contain inert ingredients with no active pharmaceutical component and produce therapeutic effects primarily through the placebo effect. Used for Clinical trial control comparator (indication-dependent on parent trial).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":false,"trials":true,"score":3}}