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

Primary Purpose

Candidiasis, Bacterial Vaginosis

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Clindamycin 100mg and Ketoconazole 400mg
Tetracycline 100mg and Amphotericin B 50mg
Sponsored by
Zodiac Produtos Farmaceuticos S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Mixed-type vaginosis
  • Bacterial vaginosis
  • Candidiasis

Exclusion Criteria:

  • Pregnancy
  • Vaginal bleeding
  • History of recurrent vaginosis

Sites / Locations

  • Vox Femina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clindamycin 100mg and Ketoconazole 400mg

Tetracycline 100mg and Amphotericin B 50mg

Arm Description

Outcomes

Primary Outcome Measures

Efficacy based on cure rate evaluated by clinical and laboratory criteria.

Secondary Outcome Measures

Tolerability based on adverse events reports and patient's information
Safety based on adverse events reports and laboratory criterion

Full Information

First Posted
April 24, 2009
Last Updated
April 27, 2009
Sponsor
Zodiac Produtos Farmaceuticos S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT00889356
Brief Title
Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Zodiac Produtos Farmaceuticos S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Bacterial Vaginosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clindamycin 100mg and Ketoconazole 400mg
Arm Type
Experimental
Arm Title
Tetracycline 100mg and Amphotericin B 50mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Clindamycin 100mg and Ketoconazole 400mg
Intervention Description
1 vaginal capsule once a day at night
Intervention Type
Drug
Intervention Name(s)
Tetracycline 100mg and Amphotericin B 50mg
Intervention Description
One full applicator, once a day at night
Primary Outcome Measure Information:
Title
Efficacy based on cure rate evaluated by clinical and laboratory criteria.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Tolerability based on adverse events reports and patient's information
Time Frame
7 days
Title
Safety based on adverse events reports and laboratory criterion
Time Frame
7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mixed-type vaginosis Bacterial vaginosis Candidiasis Exclusion Criteria: Pregnancy Vaginal bleeding History of recurrent vaginosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rogerio Bonassi Machado, MD
Phone
+55 11 4521-6466
Email
rogeriobonassi@terra.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Paula Fabrini, MD
Phone
+55 11 4521-6466
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rogerio Bonassi Machado, MD
Organizational Affiliation
CRM Regional Council of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vox Femina
City
Jundiaí
State/Province
SP
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rogerio Bonassi Machado, MD
First Name & Middle Initial & Last Name & Degree
Rogerio Bonassi Machado, MD

12. IPD Sharing Statement

Learn more about this trial

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

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