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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
264

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 29, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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