Trial | NCT00889356  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    160
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.
Study Started
Sep 30
2009
Primary Completion
Mar 31
2010
Anticipated
Study Completion
Mar 31
2010
Anticipated
Last Update
Apr 28
2009
Estimate

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

Clindamycin 100mg and Ketoconazole 400mg Experimental

Tetracycline 100mg and Amphotericin B 50mg Active Comparator

Criteria 

Inclusion Criteria:

Mixed-type vaginosis
Bacterial vaginosis
Candidiasis

Exclusion Criteria:

Pregnancy
Vaginal bleeding
History of recurrent vaginosis
No Results Posted