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

Phase 2

Recruiting

• Conditions: Candidal Vulvovaginitis (ICD-10 Code: B37.3); Vulvovaginal Candidiasis (VVC)
• Interventions: Drug: Clotrimazole+Lactulose.; Drug: Canesten (Clotrimazole); Drug: Lactulose

• Registration Number: NCT06835361
• Lead Sponsor: AVVA Pharmaceuticals Ltd.

Brief 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.

Study Timeline

• Study Start: 2024-02-29
• Study First Submitted: 2025-01-31
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-14
• Last Update Submitted: 2025-02-14
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-09-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 264

Inclusion Criteria

• Women aged 18 to 60 years.
• Clinically and microbiologically confirmed diagnosis of candidal vulvovaginitis.
• Negative pregnancy test at screening.
• Agreement to use reliable contraception throughout the study and for 30 days after its completion.
• Signed informed consent.

Exclusion Criteria

• Pregnancy or breastfeeding.
• Diagnosed bacterial vaginosis.
• Chronic inflammatory or atrophic diseases of the female genital organs.
• History of malignant neoplasms.
• Use of systemic antibiotics or antifungal drugs within 2 weeks prior to screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clotrimazole+Lactulose	Clotrimazole+Lactulose.	Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
Canesten (Clotrimazole)	Canesten (Clotrimazole)	Vaginal tablets containing clotrimazole (100 mg)
Lactulose	Lactulose	Vaginal suppositories containing lactulose (300 mg)

Primary Outcome Measures

Name	Time	Method
Proportion (%) of patients with clinical and microbiological response (recovery)	Day 25 (Visit 4)

Secondary Outcome Measures

Name	Time	Method
Proportion (%) of patients with clinical response (recovery)	by Visits 2 (Day 8) and 3 (Day 15)
Proportion (%) of patients with microbiological recovery	by Visits 2 (Day 8) and 3 (Day 15)
Assessment of the severity of subjective and objective signs and symptoms on a 4-point scale	by Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
Patient evaluation of therapy efficacy using a 5-point scale	at Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
Change in Lactobacillus content as determined by molecular biological examination of vaginal secretions (real-time PCR) compared to baseline	by Visits 3 (Day 15) and 4 (Day 25)

Trial Locations

Locations (7)

Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk"; 🇧🇾 Minsk, Belarus

Healthcare Institution "14th Central District Polyclinic of the Partizansky District of Minsk"; 🇧🇾 Minsk, Belarus

Healthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Minsk"; 🇧🇾 Minsk, Belarus

Healthcare Institution "4th City Polyclinic" of Minsk; 🇧🇾 Minsk, Belarus

Healthcare Institution "5th City Clinical Polyclinic" of Minsk; 🇧🇾 Minsk, Belarus

State Institution "Republican Center of Medical Rehabilitation and Balneotherapy"; 🇧🇾 Minsk, Belarus

SBI RR "Regional Clinical Skin and Venereal Dispensary"; 🇷🇺 Ryazan, Ryazanskaya oblast, Russian Federation