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

Zodiac Produtos Farmaceuticos

Status and phase: Unknown; Phase 3

Conditions: Candidiasis; Bacterial Vaginosis

Treatments: Drug: Clindamycin 100mg and Ketoconazole 400mg; Drug: Tetracycline 100mg and Amphotericin B 50mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00889356

ZD 002-08

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mixed-type vaginosis
• Bacterial vaginosis
• Candidiasis

Exclusion criteria

• Pregnancy
• Vaginal bleeding
• History of recurrent vaginosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Clindamycin 100mg and Ketoconazole 400mg

Experimental group

Treatment:

Drug: Clindamycin 100mg and Ketoconazole 400mg

Tetracycline 100mg and Amphotericin B 50mg

Active Comparator group

Treatment:

Drug: Tetracycline 100mg and Amphotericin B 50mg