drugset / Trial / NCT00889356

Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis

NCT00889356

Phase 3 Unknown 160 enrolled Zodiac Produtos Farmaceuticos S.A.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-09
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amphotericin B Unknown 50 mg Other
Subject Clindamycin Unknown 100 mg Other
Subject Ketoconazole Small molecule 400 mg Other
Comparator Tetracycline Unknown 100 mg Other