Candidal Vulvovaginitis (ICD-10 Code: B37.3), Vulvovaginal Candidiasis (VVC)
Conditions
Keywords
Clotrimazole+Lactulose, Candidal Vulvovaginitis, Vulvovaginal Candidiasis, Clotrimazole, Lactulose, Antifungal Therapy, Prebiotic, Vaginal Suppositories, Canesten, Microbiological Recovery, Women's Health, Vaginal Microbiota
Brief 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.
Detailed description
The study was conducted using an adaptive design to evaluate the impact of lactulose on the course of fungal infections. The primary endpoint was the proportion of patients achieving clinical and microbiological recovery on Day 25 (Visit 4). Secondary endpoints included assessment of symptom severity, changes in Lactobacillus content, and patient satisfaction with therapy. Participants were randomized into three groups: Clotrimazole+Lactulose, Canesten, and Lactulose.
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)
Sponsors
AVVA Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Masking : Single (Evaluator-blinded)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion (%) of patients with clinical and microbiological response (recovery) | Day 25 (Visit 4) |
Secondary
| Measure | Time frame |
|---|---|
| Proportion (%) of patients with clinical response (recovery) | by Visits 2 (Day 8) and 3 (Day 15) |
| Proportion (%) of patients with microbiological recovery | by Visits 2 (Day 8) and 3 (Day 15) |
| Assessment of the severity of subjective and objective signs and symptoms on a 4-point scale | by Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25) |
| Patient evaluation of therapy efficacy using a 5-point scale | at Visits 2 (Day 8), 3 (Day 15), and 4 (Day 25) |
| Change in Lactobacillus content as determined by molecular biological examination of vaginal secretions (real-time PCR) compared to baseline | by Visits 3 (Day 15) and 4 (Day 25) |
Countries
Belarus, Russia
Contacts
Primary ContactSergey Tolmachev
Outcome results
None listed