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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,443
semi solid, single dose
semi solid, single dose
semi solid, single dose
Clinical symptom resolution.
Time frame: baseline, 7 to 10 days and 21 to 30 days
Yeast Culture for Candida
Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response
Time frame: baseline, 7 to 10 days and 21 to 30 days
Gram stain Nugent score
Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution
Time frame: baseline, 7 to 10 days and 21 to 30 days
Saline wet mount for clue cells
Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution
Time frame: baseline, 7 to 10 days and 21 to 30 days
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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
...and 123 more locations