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Sponsored by: |
KV Pharmaceutical Company |
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Information provided by: | KV Pharmaceutical Company |
ClinicalTrials.gov Identifier: | NCT00616330 |
This study will evaluate the efficacy and safety of a vaginal product compared with that of other vaginal products and placebo in the treatment of vaginal infections.
Condition | Intervention | Phase |
---|---|---|
Vulvovaginitis Vaginitis |
Drug: clindamycin phosphate/butoconazole nitrate Drug: clindamycin phosphate Drug: butoconazole nitrate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment |
Estimated Enrollment: | 900 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
clindamycin phosphate/butoconazole nitrate
|
Drug: clindamycin phosphate/butoconazole nitrate
semi solid, single dose
|
2: Active Comparator
clindamycin phosphate
|
Drug: clindamycin phosphate
semi solid, single dose
|
3: Active Comparator
butoconazole nitrate
|
Drug: butoconazole nitrate
semi solid, single dose
|
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chang Lee, MD | 877-567-7676 |
Study Director: | Chang Lee, MD | KV Pharmaceutical Company |
Responsible Party: | KV Pharmaceutical Company ( Chang Lee, MD, Vice President Clinical and Medical Affairs ) |
Study ID Numbers: | CBC-302-602-622467 |
Study First Received: | February 4, 2008 |
Last Updated: | April 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00616330 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Vulvovaginitis Clindamycin Clindamycin-2-phosphate Clotrimazole Miconazole Vaginitis Butoconazole |
Tioconazole Vaginal Diseases Genital Diseases, Female Anti-Bacterial Agents Antifungal Agents Vulvar Diseases |
Anti-Infective Agents Vulvovaginitis Clindamycin Clindamycin-2-phosphate Molecular Mechanisms of Pharmacological Action Vaginitis Butoconazole Vaginal Diseases Enzyme Inhibitors |
Pharmacologic Actions Genital Diseases, Female Anti-Bacterial Agents Protein Synthesis Inhibitors Antifungal Agents Therapeutic Uses Vulvitis Vulvar Diseases |