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NCT Number: NCT06835361

Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women 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.

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Key information

Conditions

Candidal Vulvovaginitis (ICD-10 Code: B37.3) Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginal Candidiasis (VVC) Vulvovaginitis

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk", Minsk, Minsk City, Belarus

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clotrimazole+Lactulose.

Drug

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

Canesten (Clotrimazole)

Drug

Vaginal tablets containing clotrimazole (100 mg)

Lactulose

Drug

Vaginal suppositories containing lactulose (300 mg)

Primary outcomes

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

    Time frame: Day 25 (Visit 4)

Secondary outcomes

  1. Proportion (%) of patients with clinical response (recovery)

    Time frame: by Visits 2 (Day 8) and 3 (Day 15)

  2. Proportion (%) of patients with microbiological recovery

    Time frame: by Visits 2 (Day 8) and 3 (Day 15)

  3. 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)

  4. Patient evaluation of therapy efficacy using a 5-point scale

    Time frame: at Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25)

  5. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sergey Tolmachev

CONTACT

[email protected]

+7 495 2690016

Sponsors and collaborators

Lead sponsor

AVVA Pharmaceuticals Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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