NCT01293643

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)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Vaginosis, Bacterial
• Candidiasis, Vulvovaginal

Interventions

Type	Name	Description
DRUG	100 mg clindamycin /800 mg ketoconazole vaginal ovule	1 vaginal ovule for 3 consecutive days
DRUG	100 mg tetracycline hydrochloride /50 mg amphotericin B cream	1 applicator (4 g) full of cream intravaginally for 7 to 10 days

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2011-02-10
• Last updated: 2015-08-10