Actively Recruiting
Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis
Led by AVVA Pharmaceuticals Ltd. · Updated on 2025-02-19
264
Participants Needed
7
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Pregnant or breastfeeding women
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Healthcare Institution "1st Central District Polyclinic of the Central District of Minsk"
Minsk, Minsk City, Belarus, 220004
Actively Recruiting
2
Healthcare Institution "14th Central District Polyclinic of the Partizansky District of Minsk"
Minsk, Belarus
Actively Recruiting
3
Healthcare Institution "2nd Central District Polyclinic of the Frunzensky District of Minsk"
Minsk, Belarus
Actively Recruiting
4
Healthcare Institution "4th City Polyclinic" of Minsk
Minsk, Belarus
Actively Recruiting
5
Healthcare Institution "5th City Clinical Polyclinic" of Minsk
Minsk, Belarus
Actively Recruiting
6
State Institution "Republican Center of Medical Rehabilitation and Balneotherapy"
Minsk, Belarus
Actively Recruiting
7
SBI RR "Regional Clinical Skin and Venereal Dispensary"
Ryazan, Ryazan Oblast, Russia
Actively Recruiting
Research Team
S
Sergey Tolmachev
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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