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

Phase 3

• Conditions: Candidiasis; Bacterial Vaginosis
• Interventions: Drug: Clindamycin 100mg and Ketoconazole 400mg; Drug: Tetracycline 100mg and Amphotericin B 50mg

• Registration Number: NCT00889356
• Lead Sponsor: Zodiac Produtos Farmaceuticos S.A.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-04
• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-04-27
• Last Update Submitted: 2009-04-27
• Study First Posted: 2009-04-28
• Last Update Posted: 2009-04-28
• Study Start: 2009-09
• Primary Completion: 2010-03
• Study Completion: 2010-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• Mixed-type vaginosis
• Bacterial vaginosis
• Candidiasis

Exclusion Criteria

• Pregnancy
• Vaginal bleeding
• History of recurrent vaginosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clindamycin 100mg and Ketoconazole 400mg	Clindamycin 100mg and Ketoconazole 400mg	-
Tetracycline 100mg and Amphotericin B 50mg	Tetracycline 100mg and Amphotericin B 50mg	-

Primary Outcome Measures

Name	Time	Method
Efficacy based on cure rate evaluated by clinical and laboratory criteria.	7 days

Secondary Outcome Measures

Name	Time	Method
Tolerability based on adverse events reports and patient's information	7 days
Safety based on adverse events reports and laboratory criterion	7 days

Trial Locations

Locations (1)

Vox Femina; 🇧🇷 Jundiaí, SP, Brazil