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
AVVA Pharmaceuticals Ltd.
264 participants
Feb 29, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria5
- 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.
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Interventions
Vaginal suppositories containing clotrimazole (100 mg) and lactulose (300 mg)
Vaginal tablets containing clotrimazole (100 mg)
Vaginal suppositories containing lactulose (300 mg)
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT06835361