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

RecruitingPhase 2, Phase 3Ages 18 Years - 60 YearsFemaleAVVA Pharmaceuticals Ltd.
NCT06835361 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • Clotrimazole+Lactulose.
  • Canesten (Clotrimazole)
  • Lactulose
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Where

7 sites
Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk"
Minsk, Belarus
Healthcare Institution "14th Central District Polyclinic of the Partizansky District of Minsk"
Minsk, Belarus
Healthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Minsk"
Minsk, Belarus
Healthcare Institution "4th City Polyclinic" of Minsk
Minsk, Belarus
Healthcare Institution "5th City Clinical Polyclinic" of Minsk
Minsk, Belarus
State Institution "Republican Center of Medical Rehabilitation and Balneotherapy"
Minsk, Belarus
SBI RR "Regional Clinical Skin and Venereal Dispensary"
Ryazan, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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