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

NCT01293643 Phase 3 COMPLETED

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.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	COMPLETED
Enrolment	99
Start date	2010-05
Completion	2011-01

Conditions

• Vaginosis, Bacterial
• Candidiasis, Vulvovaginal

Interventions

• 100 mg clindamycin /800 mg ketoconazole vaginal ovule
• 100 mg tetracycline hydrochloride /50 mg amphotericin B cream

Primary outcomes

• Percentage of participants that obtain clinical cure — Baseline up to Day 10
• Percentage of participants that obtain microbiological cure — Baseline up to Day 10