RecruitingPhase 2/3

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

Belarus264 participantsStarted 2024-02-29

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Day 25 (Visit 4)

Trial details

NCT IDNCT06835361

SponsorAVVA Pharmaceuticals Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-30

Contact for this trial

Sergey Tolmachev

+7 495 2690016 tolmachev@rnd.avvapharma.com

View on ClinicalTrials.gov More Candidal Vulvovaginitis (ICD-10 Code: B37.3) trials