A Study to Compare the Efficacy and Safety of a Combination of Ketoconazole and Clindamycin Compared to Tetracycline/Amphotericin B Combination Cream for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis (P08077)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: February 10, 2011
Last Update Posted: August 10, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This is a study to compare the safety and efficacy of the use of a intravaginal ovule containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream containing a combination Tetracycline and Amphotericin B for the treatment of bacterial vaginosis and/or mixed or isolated vaginal candidiasis.
|Vaginosis, Bacterial Candidiasis, Vulvovaginal||Drug: 100 mg clindamycin /800 mg ketoconazole vaginal ovule Drug: 100 mg tetracycline hydrochloride /50 mg amphotericin B cream||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase 3b, Comparative and Randomized Study to Assess the Efficacy and Safety of an Intravaginal Ovule Combination of Ketoconazole and Clindamycin Compared With an Intravaginal Cream Combination of Tetracycline and Amphotericin B for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis, Either Mixed or Isolated|
Resource links provided by NLM:
Drug Information available for: Tetracycline Tetracycline hydrochloride Amphotericin B Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin palmitate hydrochloride Clindamycin palmitate Ketoconazole Liposomal Amphotericin BU.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Percentage of participants that obtain clinical cure [ Time Frame: Baseline up to Day 10 ]
- Percentage of participants that obtain microbiological cure [ Time Frame: Baseline up to Day 10 ]
|Study Start Date:||May 2010|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
|Experimental: clindamycin/ketoconazole combination||
Drug: 100 mg clindamycin /800 mg ketoconazole vaginal ovule
1 vaginal ovule for 3 consecutive days
|Active Comparator: tetracycline hydrochloride/amphotericin B combination||
Drug: 100 mg tetracycline hydrochloride /50 mg amphotericin B cream
1 applicator (4 g) full of cream intravaginally for 7 to 10 days
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