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

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2010

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Clindamycin 100mg and Ketoconazole 400mg
  • Active Comparator: Tetracycline 100mg and Amphotericin B 50mg

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy based on cure rate evaluated by clinical and laboratory criteria.
    • Time Frame: 7 days

Secondary Measures

  • Tolerability based on adverse events reports and patient’s information
    • Time Frame: 7 days
  • Safety based on adverse events reports and laboratory criterion
    • Time Frame: 7 days

Participating in This Clinical Trial

Inclusion Criteria

  • Mixed-type vaginosis – Bacterial vaginosis – Candidiasis Exclusion Criteria:

  • Pregnancy – Vaginal bleeding – History of recurrent vaginosis

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zodiac Produtos Farmaceuticos S.A.
  • Provider of Information About this Clinical Study
    • Julio Cesar Nophal de Carvalho, Zodiac Produtos Farmaceuticos
  • Overall Official(s)
    • Rogerio Bonassi Machado, MD, Principal Investigator, CRM Regional Council of Medicine
  • Overall Contact(s)
    • Rogerio Bonassi Machado, MD, +55 11 4521-6466, rogeriobonassi@terra.com.br

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