Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis
Information source: Zodiac Produtos Farmaceuticos S.A.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis; Bacterial Vaginosis
Intervention: Clindamycin 100mg and Ketoconazole 400mg (Drug); Tetracycline 100mg and Amphotericin B 50mg (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Zodiac Produtos Farmaceuticos S.A. Official(s) and/or principal investigator(s):
Rogerio Bonassi Machado, MD, Principal Investigator, Affiliation: CRM Regional Council of Medicine
Overall contact:
Rogerio Bonassi Machado, MD, Phone: +55 11 4521-6466, Email: rogeriobonassi@terra.com.br
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Efficacy based on cure rate evaluated by clinical and laboratory criteria.
Secondary outcome: Tolerability based on adverse events reports and patient's informationSafety based on adverse events reports and laboratory criterion
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Mixed-type vaginosis
- Bacterial vaginosis
- Candidiasis
Exclusion Criteria:
- Pregnancy
- Vaginal bleeding
- History of recurrent vaginosis
Locations and Contacts
Rogerio Bonassi Machado, MD, Phone: +55 11 4521-6466, Email: rogeriobonassi@terra.com.br
Vox Femina, Jundiaí, SP, Brazil
Additional Information
Starting date: September 2009
Ending date: March 2010
Last updated: April 27, 2009
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