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Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 19, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
This study aims to compare the efficacy and safety of the combination drug Clotrimazole+Lactulose with the monocomponent product Canesten® (clotrimazole) in adult women diagnosed with candidal vulvovaginitis. The primary objective was to confirm the superiority of the combination drug in terms of clinical and microbiological response on Day 25 of the study.
Trial Details
NCT Number NCT06835361
Lead Sponsor AVVA Pharmaceuticals Ltd.
Conditions
(from sponsor)		 Candidal Vulvovaginitis (ICD-10 Code: B37.3), Vulvovaginal Candidiasis (VVC)
Related terms Candidiasis, Vulvovaginal
Enrollment 264 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov