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

Last updated: February 14, 2025
Sponsor: AVVA Pharmaceuticals Ltd.
Overall Status: Active - Recruiting

Phase

2/3

Condition

Vaginitis

Soft Tissue Infections

Yeast Infections

Treatment

Clotrimazole+Lactulose.

Lactulose

Canesten (Clotrimazole)

Clinical Study ID

NCT06835361
Clotrimazole+Lactulose-II/III
  • Ages 18-60
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 afterits completion.

  • Signed informed consent.

Exclusion

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

Total Participants: 264
Treatment Group(s): 3
Primary Treatment: Clotrimazole+Lactulose.
Phase: 2/3
Study Start date:
February 29, 2024
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

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

    Minsk,
    Belarus

    Active - Recruiting

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

    Minsk, 220004
    Belarus

    Active - Recruiting

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

    Minsk,
    Belarus

    Active - Recruiting

  • Healthcare Institution "4th City Polyclinic" of Minsk

    Minsk,
    Belarus

    Active - Recruiting

  • Healthcare Institution "5th City Clinical Polyclinic" of Minsk

    Minsk,
    Belarus

    Active - Recruiting

  • State Institution "Republican Center of Medical Rehabilitation and Balneotherapy"

    Minsk,
    Belarus

    Active - Recruiting

  • SBI RR "Regional Clinical Skin and Venereal Dispensary"

    Ryazan, Ryazanskaya oblast
    Russian Federation

    Active - Recruiting

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