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Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis
Sponsor: AVVA Pharmaceuticals Ltd.
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.
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
Key Details
Gender
FEMALE
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
264
Start Date
2024-02-29
Completion Date
2025-11-30
Last Updated
2025-02-19
Healthy Volunteers
No
Interventions
Clotrimazole+Lactulose.
Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
Canesten (Clotrimazole)
Vaginal tablets containing clotrimazole (100 mg)
Lactulose
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