This study will evaluate the efficacy and safety of a vaginal product compared with that of another vaginal product in the treatment of vaginal infections...
Date First Received: June 9, 2008
Last Updated: August 4, 2008
Verified by: KV Pharmaceutical Company, August 2008
Clinical Trial Phase: Phase 3 | Start Date: May 2008
Overall Status: Recruiting
Estimated Enrollment: 500
Brief Summary
Condition Keyword(s):
This study will evaluate the efficacy and safety of a vaginal product compared with that of another vaginal product in the treatment of vaginal infections.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Study Primary Completion Date: May 2010
Intervention(s) in this Clinical Trial
- Drug: clindamycin phosphate/butoconazole nitrate
- semi-solid, single dose
- Drug: butoconazole nitrate
- semi-solid, single dose
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- clindamycin phosphate/butoconazole nitrate
- Active Comparator: 2
- butoconazole nitrate
Outcome Measures for this Clinical Trial
Primary Measures
- The primary outcome measure of the study will be clinical symptom resolution
- Time Frame: baseline, 7 to 10 days and 21 to 30 days
Safety Issue?: No
- Time Frame: baseline, 7 to 10 days and 21 to 30 days
Secondary Measures
- Secondary outcome measures will include laboratory assessments of presence or absence of vaginal infection.
- Time Frame: baseline, 7 to 10 days and 21 to 30 days
Safety Issue?: No
- Time Frame: baseline, 7 to 10 days and 21 to 30 days
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Patients must have a clinical diagnosis of vaginal infection.
- Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.
Exclusion Criteria:
- Patients must not have any other infections
- May not be pregnant or nursing
- May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 16 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: KV Pharmaceutical Company
Overall Clinical Trial Officials and Contacts
Chang Lee, MD Study Director KV Pharmaceutical Company
Overall Contact: Chang Lee, MD 877-567-7676
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00694928
Study ID Number: CBC-303-603-622467
ClinicalTrials.gov Identifier: NCT00694928
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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