NCT00889356
Unknown
Phase 3
Phase III, Open Label, Randomized, Multicenter Study to Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, Compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream for the Treatment of Bacterial Vaginosis and Candidiasis Isolatedly or in Association (Mixed-Type Vaginosis)
Zodiac Produtos Farmaceuticos S.A.1 site in 1 country160 target enrollmentSeptember 2009
Overview
- Phase
- Phase 3
- Intervention
- Clindamycin 100mg and Ketoconazole 400mg
- Conditions
- Candidiasis
- Sponsor
- Zodiac Produtos Farmaceuticos S.A.
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Efficacy based on cure rate evaluated by clinical and laboratory criteria.
- Last Updated
- 17 years ago
Overview
Brief Summary
The purpose of this study is to determine the Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Mixed-type vaginosis
- •Bacterial vaginosis
- •Candidiasis
Exclusion Criteria
- •Pregnancy
- •Vaginal bleeding
- •History of recurrent vaginosis
Arms & Interventions
Clindamycin 100mg and Ketoconazole 400mg
Intervention: Clindamycin 100mg and Ketoconazole 400mg
Tetracycline 100mg and Amphotericin B 50mg
Intervention: Tetracycline 100mg and Amphotericin B 50mg
Outcomes
Primary Outcomes
Efficacy based on cure rate evaluated by clinical and laboratory criteria.
Time Frame: 7 days
Secondary Outcomes
- Tolerability based on adverse events reports and patient's information(7 days)
- Safety based on adverse events reports and laboratory criterion(7 days)
Study Sites (1)
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