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)

Phase 3

Completed

• Conditions: Vaginosis, Bacterial; Candidiasis, Vulvovaginal
• Interventions: Drug: 100 mg clindamycin /800 mg ketoconazole vaginal ovule; Drug: 100 mg tetracycline hydrochloride /50 mg amphotericin B cream

• Registration Number: NCT01293643
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-07
• Last Update Posted: 2015-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 99

Inclusion Criteria

• Diagnosis of vaginal candidiasis
• No Trichomonas vaginalis or any other protozoa
• No clinical evidences of infection by Neisseria gonorrhoeae, Chlamydia trachomatis, or viral infections

Exclusion Criteria

• Known sensitivity to the formula components
• Pregnant or nursing patients
• Any gynecological condition contraindicating the use of vaginal ovule or cream.
• Use of any other local or systemic bactericidal, anti-protozoa or antifungal agent within the 2 weeks prior to the study start or during it
• Presence of other sexually transmitted diseases (except from Candidal vaginitis).
• History of recurrent candidiasis (≥4 episodes per year)
• Use of intra-uterine device, spermicides, or diaphragms
• Has metabolic or immune disorder
• Has abnormal uterine bleeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clindamycin/ketoconazole combination	100 mg clindamycin /800 mg ketoconazole vaginal ovule	-
tetracycline hydrochloride/amphotericin B combination	100 mg tetracycline hydrochloride /50 mg amphotericin B cream	-

Primary Outcome Measures

Name	Time	Method
Percentage of participants that obtain clinical cure	Baseline up to Day 10
Percentage of participants that obtain microbiological cure	Baseline up to Day 10