NCT00889356

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

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Zodiac Produtos Farmaceuticos S.A. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Candidiasis
• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	Clindamycin 100mg and Ketoconazole 400mg	1 vaginal capsule once a day at night
DRUG	Tetracycline 100mg and Amphotericin B 50mg	One full applicator, once a day at night

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2009-04-28
• Last updated: 2009-04-28

Locations

1 site across 1 country: Brazil