Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
NCT ID: NCT00889356
Last Updated: 2009-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
160 participants
INTERVENTIONAL
2009-09-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Clindamycin 100mg and Ketoconazole 400mg
Clindamycin 100mg and Ketoconazole 400mg
1 vaginal capsule once a day at night
Tetracycline 100mg and Amphotericin B 50mg
Tetracycline 100mg and Amphotericin B 50mg
One full applicator, once a day at night
Interventions
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Clindamycin 100mg and Ketoconazole 400mg
1 vaginal capsule once a day at night
Tetracycline 100mg and Amphotericin B 50mg
One full applicator, once a day at night
Eligibility Criteria
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Inclusion Criteria
* Bacterial vaginosis
* Candidiasis
Exclusion Criteria
* Vaginal bleeding
* History of recurrent vaginosis
18 Years
50 Years
FEMALE
No
Sponsors
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Zodiac Produtos Farmaceuticos S.A.
INDUSTRY
Responsible Party
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Zodiac Produtos Farmaceuticos
Principal Investigators
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Rogerio Bonassi Machado, MD
Role: PRINCIPAL_INVESTIGATOR
CRM Regional Council of Medicine
Locations
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Vox Femina
Jundiaí, São Paulo, Brazil
Countries
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Central Contacts
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Paula Fabrini, MD
Role: CONTACT
Facility Contacts
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Rogerio Bonassi Machado, MD
Role: primary
Other Identifiers
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ZD 002-08
Identifier Type: -
Identifier Source: org_study_id
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