Vaginal Infection Study 2
- Conditions
- Vaginal Infection
- Interventions
- Registration Number
- NCT00694928
- Lead Sponsor
- Lumara Health, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 843
- 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 2 butoconazole nitrate butoconazole nitrate
- 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 (73)
Brookwood Ob-GYN, PC/Women's Medical Plaza
🇺🇸Birmingham, Alabama, United States
Drug Research Analysis Corp
🇺🇸Montgomery, Alabama, United States
Drug Research and Analysis Corp.
🇺🇸Montgomery, Alabama, United States
Ob/Gyn Associates
🇺🇸Jonesboro, Arkansas, United States
The Woman's Clinic, PA
🇺🇸Little Rock, Arkansas, United States
Peak Health Medical Group
🇺🇸Los Angeles, California, United States
Women's Health Care at Frost Street
🇺🇸San Diego, California, United States
Steven Freedman, MD, Inc.
🇺🇸West Hills, California, United States
Red Rocks OB/GYN
🇺🇸Lakewood, Colorado, United States
SHE Medical Center
🇺🇸Hartford, Connecticut, United States
Scroll for more (63 remaining)Brookwood Ob-GYN, PC/Women's Medical Plaza🇺🇸Birmingham, Alabama, United States