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

February 14, 2025 updated by: AVVA Pharmaceuticals Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

264

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belarus
      • Minsk, Belarus, 220004
        • Recruiting
        • Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk"
        • Contact:
      • Minsk, Belarus
        • Recruiting
        • Healthcare Institution "14th Central District Polyclinic of the Partizansky District of Minsk"
        • Contact:
          • Elena V Golovko
          • Phone Number: +375 17 200 18 96
          • Email: info@14crp.by
      • Minsk, Belarus
        • Recruiting
        • Healthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Minsk"
        • Contact:
      • Minsk, Belarus
        • Recruiting
        • Healthcare Institution "4th City Polyclinic" of Minsk
        • Contact:
          • Elena A Malyavskaya
          • Phone Number: +375 17 374-67-69
          • Email: info@4gp.by
      • Minsk, Belarus
        • Recruiting
        • Healthcare Institution "5th City Clinical Polyclinic" of Minsk
        • Contact:
          • Veronika D Babkova
          • Phone Number: +375 17 278 10 70
          • Email: info@5gp.by
      • Minsk, Belarus
        • Recruiting
        • State Institution "Republican Center of Medical Rehabilitation and Balneotherapy"
        • Contact:
  • Russian Federation
    • Ryazanskaya oblast
      • Ryazan, Ryazanskaya oblast, Russian Federation
        • Recruiting
        • SBI RR "Regional Clinical Skin and Venereal Dispensary"
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clotrimazole+Lactulose
Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
Drug: Clotrimazole+Lactulose.
Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
Active Comparator: Canesten (Clotrimazole)
Vaginal tablets containing clotrimazole (100 mg)
Drug: Canesten (Clotrimazole)
Vaginal tablets containing clotrimazole (100 mg)
Placebo Comparator: Lactulose
Vaginal suppositories containing lactulose (300 mg)
Drug: Lactulose
Vaginal suppositories containing lactulose (300 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion (%) of patients with clinical and microbiological response (recovery)
Time Frame: Day 25 (Visit 4)
Day 25 (Visit 4)

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion (%) of patients with clinical response (recovery)
Time Frame: by Visits 2 (Day 8) and 3 (Day 15)
by Visits 2 (Day 8) and 3 (Day 15)
Proportion (%) of patients with microbiological recovery
Time Frame: by Visits 2 (Day 8) and 3 (Day 15)
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
Time Frame: by Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
by Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
Patient evaluation of therapy efficacy using a 5-point scale
Time Frame: at Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)
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
Time Frame: by Visits 3 (Day 15) and 4 (Day 25)
by Visits 3 (Day 15) and 4 (Day 25)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AVVA Pharmaceuticals Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 29, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Clotrimazole+Lactulose-II/III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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