Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis
Recruiting
Phase 2
Phase 3
Interventional Study
Candidal Vulvovaginitis (ICD-10 Code: B37.3)
Vulvovaginal Candidiasis (VVC)
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Female
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 264 (estimated)
- Sponsor
- AVVA Pharmaceuticals Ltd. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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.…
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