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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of participants that obtain clinical cure	Baseline up to Day 10
Percentage of participants that obtain microbiological cure	Baseline up to Day 10

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Estimate): August 10, 2015
• Last Update Submitted That Met QC Criteria: August 7, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Mycoses; Vulvar Diseases; Vaginitis; Vulvitis; Vulvovaginitis; Candidiasis; Vaginal Diseases; Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Amebicides; 14-alpha Demethylase Inhibitors; Ketoconazole; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Amphotericin B; Liposomal amphotericin B; Tetracycline
• Other Study ID Numbers: P08077; BR 001-09 (Other Identifier: Schering Study Number)