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)
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2009
CompletedFirst Posted
Study publicly available on registry
April 28, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedApril 28, 2009
April 1, 2009
6 months
April 24, 2009
April 27, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy based on cure rate evaluated by clinical and laboratory criteria.
7 days
Secondary Outcomes (2)
Tolerability based on adverse events reports and patient's information
7 days
Safety based on adverse events reports and laboratory criterion
7 days
Study Arms (2)
Clindamycin 100mg and Ketoconazole 400mg
EXPERIMENTALTetracycline 100mg and Amphotericin B 50mg
ACTIVE COMPARATORInterventions
1 vaginal capsule once a day at night
One full applicator, once a day at night
Eligibility Criteria
You may qualify if:
- Mixed-type vaginosis
- Bacterial vaginosis
- Candidiasis
You may not qualify if:
- Pregnancy
- Vaginal bleeding
- History of recurrent vaginosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vox Femina
Jundiaí, São Paulo, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rogerio Bonassi Machado, MD
CRM Regional Council of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 24, 2009
First Posted
April 28, 2009
Study Start
September 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
April 28, 2009
Record last verified: 2009-04