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

Last updated: April 27, 2009
Sponsor: Zodiac Produtos Farmaceuticos S.A.
Overall Status: Trial Status Unknown

Phase

3

Condition

Gynecological Infections

Systemic Fungal Infections

Sexually Transmitted Diseases (Stds)

Treatment

N/A

Clinical Study ID

NCT00889356
ZD 002-08
  • Ages 18-50
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Mixed-type vaginosis

  • Bacterial vaginosis

  • Candidiasis

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Vaginal bleeding

  • History of recurrent vaginosis

Study Design

Total Participants: 160
Study Start date:
September 01, 2009
Estimated Completion Date:
March 31, 2010

Connect with a study center

  • Vox Femina

    Jundiaí, SP
    Brazil

    Site Not Available

  • Vox Femina

    Jundiaí, SP
    Brazil

    Site Not Available

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