NCT06835361

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

International Open-label Randomized Comparative Clinical Study of Efficacy and Safety of Clotrimazole+Lactulose, Vaginal Suppositories (AVVA RUS JSC, Russia) Vs. a Clotrimazole Monocomponent Product in Adult Female Patients with Candidal Vaginitis/vulvovaginitis

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: AVVA Pharmaceuticals Ltd. · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study was conducted using an adaptive design to evaluate the impact of lactulose on the course of fungal infections. The primary endpoint was the proportion of patients achieving clinical and microbiological recovery on Day 25 (Visit 4). Secondary endpoints included assessment of symptom severity, changes in Lactobacillus content, and patient satisfaction with therapy. Participants were randomized into three groups: Clotrimazole+Lactulose, Canesten, and Lactulose.

Conditions

• Candidal Vulvovaginitis (ICD-10 Code: B37.3)
• Vulvovaginal Candidiasis (VVC)

Interventions

Type	Name	Description
DRUG	Clotrimazole+Lactulose.	Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
DRUG	Canesten (Clotrimazole)	Vaginal tablets containing clotrimazole (100 mg)
DRUG	Lactulose	Vaginal suppositories containing lactulose (300 mg)

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-09-30
• Completion: 2025-11-30
• First posted: 2025-02-19
• Last updated: 2025-02-19

Locations

7 sites across 2 countries: Belarus, Russia