drugset / Trial / NCT06835361

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

NCT06835361

Phase 2/3 Recruiting 264 enrolled AVVA Pharmaceuticals Ltd.
RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2024-02-29
Primary completion
2025-09-30
Completion
2025-11-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Clotrimazole Unknown 100 mg Other
Subject Lactulose Other / unclassified 300 mg Other