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Recruiting NCT06835361

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

Phase II / Phase III Interventional Candidal Vulvovaginitis (ICD-10 Code: B37.3) Vulvovaginal Candidiasis (VVC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clotrimazole+Lactulose., Canesten (Clotrimazole), Lactulose.
Who it may be relevant to
Registry conditions: Candidal Vulvovaginitis (ICD-10 Code: B37.3), Vulvovaginal Candidiasis (VVC). Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belarus, Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

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.

Interventions

  • Drug Clotrimazole+Lactulose.
    Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
  • Drug Canesten (Clotrimazole)
    Vaginal tablets containing clotrimazole (100 mg)
  • Drug Lactulose
    Vaginal suppositories containing lactulose (300 mg)

Primary outcome measures

  • Proportion (%) of patients with clinical and microbiological response (recovery) [Time frame: Day 25 (Visit 4)]
Secondary outcome measures (5)
  • Proportion (%) of patients with clinical response (recovery) [Time frame: 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)]
  • 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)]
  • Patient evaluation of therapy efficacy using a 5-point scale [Time frame: 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Belarus · 6 centers
  • Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk" — Minsk
  • Healthcare Institution "14th Central District Polyclinic of the Partizansky District of Mi — Minsk
  • Healthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Mins — Minsk
  • Healthcare Institution "4th City Polyclinic" of Minsk — Minsk
  • Healthcare Institution "5th City Clinical Polyclinic" of Minsk — Minsk
  • State Institution "Republican Center of Medical Rehabilitation and Balneotherapy" — Minsk
Russia · 1 center
  • SBI RR "Regional Clinical Skin and Venereal Dispensary" — Ryazan

Identifiers

NCT: NCT06835361 · Clotrimazole+Lactulose-II/III

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗