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

NCT06835361 | Recruiting Phase 2

• 1 other identifier: Clotrimazole+Lactulose-II/III
• Study Type: interventional
• Target: 264
• Locations: 2 countries
• Sites: 7

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.

Conditions

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

Keywords

Clotrimazole+Lactulose; Candidal Vulvovaginitis; Vulvovaginal Candidiasis; Clotrimazole; Lactulose; Antifungal Therapy; Prebiotic; Vaginal Suppositories; Canesten; Microbiological Recovery; Women's Health; Vaginal Microbiota

Outcome Measures

Primary Outcomes (1)

• Proportion (%) of patients with clinical and microbiological response (recovery)

  Day 25 (Visit 4)

Secondary Outcomes (5)

• 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)

Study Arms (3)

Clotrimazole+Lactulose

EXPERIMENTAL

Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)

Drug: Clotrimazole+Lactulose.

Canesten (Clotrimazole)

ACTIVE COMPARATOR

Vaginal tablets containing clotrimazole (100 mg)

Drug: Canesten (Clotrimazole)

Lactulose

PLACEBO COMPARATOR

Vaginal suppositories containing lactulose (300 mg)

Drug: Lactulose

Interventions

Clotrimazole+Lactulose. DRUG

Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)

Clotrimazole+Lactulose

Canesten (Clotrimazole) DRUG

Vaginal tablets containing clotrimazole (100 mg)

Canesten (Clotrimazole)

Lactulose DRUG

Vaginal suppositories containing lactulose (300 mg)

Lactulose

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AVVA Pharmaceuticals Ltd.: lead

Study Sites (7)

Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk"

Minsk, Minsk City, 220004, Belarus

RECRUITING

Healthcare Institution "14th Central District Polyclinic of the Partizansky District of Minsk"

Minsk, Belarus

RECRUITING

Healthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Minsk"

Minsk, Belarus

RECRUITING

Healthcare Institution "4th City Polyclinic" of Minsk

Minsk, Belarus

RECRUITING

Healthcare Institution "5th City Clinical Polyclinic" of Minsk

Minsk, Belarus

RECRUITING

State Institution "Republican Center of Medical Rehabilitation and Balneotherapy"

Minsk, Belarus

RECRUITING

SBI RR "Regional Clinical Skin and Venereal Dispensary"

Ryazan, Ryazan Oblast, Russia

RECRUITING

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Clotrimazole; Lactulose

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Central Study Contacts

Sergey Tolmachev

CONTACT

+7 495 2690016; tolmachev@rnd.avvapharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking : Single (Evaluator-blinded)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 19, 2025
• Study Start: February 29, 2024
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1); BE (6)