CTRI/2010/091/000120
Completed
Phase 3
Evaluation of efficacy and safety of butoconazole versus clotrimazole in the treatment of vulvovaginal candidiasis: a randomized, open label, active controlled, multicentric study.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sun Pharmaceutical Industries Ltd.
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Female patients aged between 18 and 65 years.
- •2\. Has a primary diagnosis of vulvovaginal candidiasis.
- •3\. Patient willing to give their informed consent.
Exclusion Criteria
- •1\. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
- •2\. Patients with vaginal trichomonas infection or clue cells of Gardnerella vaginalis vaginitis.
- •3\. Patients having history of recurrent vulvovaginal candidiasis, defined as occurrence of four or more than four episodes in the previous 12 months.
- •4\. Patients having hypersensitivity to imidazole derivatives.
- •5\. Patients on the treatment with an oral or intravaginal antifungal medication during a week before enrollment.
- •6\. Patients on therapy with antibiotics, systemic antimycotics, corticosteroids, or immunosuppressive drugs.
- •7\. Menstruating patients or patients expecting menses during treatment period.
Outcomes
Primary Outcomes
Not specified
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