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
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Belarus
Healthcare Institution 14th Central District Polyclinic of the Partizansky District of Minsk
RECRUITING
Minsk
Healthcare Institution 1st Central District Polyclinic of the Central District of Minsk
RECRUITING
Minsk
Healthcare Institution 2nd Central District Polyclinic of the Frunzensky District of Minsk
RECRUITING
Minsk
Healthcare Institution 4th City Polyclinic of Minsk
RECRUITING
Minsk
Healthcare Institution 5th City Clinical Polyclinic of Minsk
RECRUITING
Minsk
State Institution Republican Center of Medical Rehabilitation and Balneotherapy
RECRUITING
Minsk
Russian Federation
SBI RR Regional Clinical Skin and Venereal Dispensary
RECRUITING
Ryazan
Contact Information
Primary
Sergey Tolmachev
tolmachev@rnd.avvapharma.com
+7 495 2690016
Time Frame
Start Date: 2024-02-29
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 264
Treatments
Experimental: Clotrimazole+Lactulose
Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
Active_comparator: Canesten (Clotrimazole)
Vaginal tablets containing clotrimazole (100 mg)
Placebo_comparator: Lactulose
Vaginal suppositories containing lactulose (300 mg)
Related Therapeutic Areas
Sponsors
Leads: AVVA Pharmaceuticals Ltd.