Vaginal Infection Study
- Conditions
- VulvovaginitisVaginitis
- Interventions
- Registration Number
- NCT00616330
- Lead Sponsor
- Lumara Health, Inc.
- Brief Summary
This study will evaluate the efficacy and safety of a vaginal product compared with that of other vaginal products in the treatment of vaginal infections.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1443
- Patients must have a clinical diagnosis of vaginal infection.
- Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 clindamycin phosphate/butoconazole nitrate clindamycin phosphate/butoconazole nitrate 3 butoconazole nitrate butoconazole nitrate 2 clindamycin phosphate clindamycin phosphate
- Primary Outcome Measures
Name Time Method Clinical symptom resolution. baseline, 7 to 10 days and 21 to 30 days
- Secondary Outcome Measures
Name Time Method Yeast Culture for Candida baseline, 7 to 10 days and 21 to 30 days Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response
Gram stain Nugent score baseline, 7 to 10 days and 21 to 30 days Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution
Saline wet mount for clue cells baseline, 7 to 10 days and 21 to 30 days Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution
Trial Locations
- Locations (130)
Clinical Research Consultants, Inc
🇺🇸Birmingham, Alabama, United States
Jefferson Clinic, PC
🇺🇸Birmingham, Alabama, United States
Choice Research, LLC
🇺🇸Enterprise, Alabama, United States
Star W. Research
🇺🇸Chandler, Arizona, United States
Precision Trials, LLC/Desert West OB/GYN
🇺🇸Glendale, Arizona, United States
Women's Health Research
🇺🇸Phoenix, Arizona, United States
Precision Trials LLC
🇺🇸Phoenix, Arizona, United States
Visions Clinical Research - Tucson
🇺🇸Tucson, Arizona, United States
NEA Women's Clinic
🇺🇸Jonesboro, Arkansas, United States
Arkansas Primary Care Clinic, PA
🇺🇸Little Rock, Arkansas, United States
Scroll for more (120 remaining)Clinical Research Consultants, Inc🇺🇸Birmingham, Alabama, United States