RecruitingPhase 2Phase 3NCT06835361

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

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

Sponsor

AVVA Pharmaceuticals Ltd.

Enrollment

264 participants

Start Date

Feb 29, 2024

Study Type

INTERVENTIONAL

Conditions

Candidal Vulvovaginitis (ICD-10 Code: B37.3)Vulvovaginal Candidiasis (VVC)

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

Sex: FEMALEMin Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Canesten (Clotrimazole), a drug called Clotrimazole+Lactulose., and others for people with candidal vulvovaginitis (icd-10 code: b37.3) and vulvovaginal candidiasis (vvc). The study is currently recruiting participants at 7 locations. People eligible for this study include women aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGClotrimazole+Lactulose.

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

DRUGCanesten (Clotrimazole)

Vaginal tablets containing clotrimazole (100 mg)

DRUGLactulose

Vaginal suppositories containing lactulose (300 mg)

Locations(7)

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

Minsk, Minsk City, 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, Ryazan Oblast, Russia

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NCT06835361

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