Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis

Phase III, Open Label, Randomized, Multicenter Study to Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, Compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream for the Treatment of Bacterial Vaginosis and Candidiasis Isolatedly or in Association (Mixed-Type Vaginosis)

The purpose of this study is to determine the Efficacy, Tolerability & Safety of Combination of Clindamycin 100mg and Ketoconazole 400mg in Vaginal Capsules, used for 7 consecutive days in patients with Mixed-Type Vaginosis compared to Combination of Tetracycline 100mg and Amphotericin B 50mg in Vaginal Cream.

Study Overview

• Status: Unknown
• Conditions: Candidiasis; Bacterial Vaginosis
• Intervention / Treatment: Drug: Clindamycin 100mg and Ketoconazole 400mg; Drug: Tetracycline 100mg and Amphotericin B 50mg

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Rogerio Bonassi Machado, MD; Phone Number: +55 11 4521-6466; Email: rogeriobonassi@terra.com.br
• Study Contact Backup: Name: Paula Fabrini, MD; Phone Number: +55 11 4521-6466

Study Locations

• Brazil
  • SP
    • Jundiaí, SP, Brazil
      • Vox Femina
      • Contact: Rogerio Bonassi Machado, MD
      • Principal Investigator: Rogerio Bonassi Machado, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Mixed-type vaginosis
• Bacterial vaginosis
• Candidiasis

Exclusion Criteria:

• Pregnancy
• Vaginal bleeding
• History of recurrent vaginosis

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 100mg and Ketoconazole 400mg	Drug: Clindamycin 100mg and Ketoconazole 400mg; 1 vaginal capsule once a day at night
Active Comparator: Tetracycline 100mg and Amphotericin B 50mg	Drug: Tetracycline 100mg and Amphotericin B 50mg; One full applicator, once a day at night

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy based on cure rate evaluated by clinical and laboratory criteria.	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Tolerability based on adverse events reports and patient's information	7 days
Safety based on adverse events reports and laboratory criterion	7 days

Collaborators and Investigators

• Sponsor: Zodiac Produtos Farmaceuticos S.A.
• Investigators: Principal Investigator: Rogerio Bonassi Machado, MD, CRM Regional Council of Medicine

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): March 1, 2010
• Study Completion (Anticipated): March 1, 2010

Study Registration Dates

• First Submitted: April 24, 2009
• First Submitted That Met QC Criteria: April 27, 2009
• First Posted (Estimate): April 28, 2009

Study Record Updates

• Last Update Posted (Estimate): April 28, 2009
• Last Update Submitted That Met QC Criteria: April 27, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Mycoses; Vaginitis; Candidiasis; Vaginal Diseases; Vaginosis, Bacterial; 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: ZD 002-08