The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
Precision Trials
Phoenix, Arizona, United States
Downtown Women's Health Care
Denver, Colorado, United States
Clinical Research Center of Nevada
Las Vegas, Nevada, United States
Bexar Clinical Trials, LLC
Irving, Texas, United States
Number of Women With Clinical Cure as a Measure of Efficacy
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Time frame: Day 21-30
Number of Women With Clinical Cure as a Measure of Efficacy
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
Time frame: Day 9-12
Number of Women With Nugent Cure as a Measure of Efficacy
Number of women with Nugent cure, defined as a Nugent score 0-3 (normal flora), when a score of 7-10 (BV flora) was determined at Baseline.
Time frame: Day 9-30
Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)
Number of women with absence of patient-reported vaginal odor, as determined by responses in a symptom questionnaire as to whether or not they had vaginal odor.
Time frame: Day 9-30
Incidence of Genital Adverse Events Potentially Related to Treatment
Number of women who experience signs/symptoms of genital irritation potentially related to treatment, by solicited reporting of specific AEs as a measure of safety.
Time frame: For the duration of the study (up to Visit Day 21-30)
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Vaginal gel
Tidewater Clinical Research Inc
Virginia Beach, Virginia, United States