Vaginal Infection Clinical Trial
Official title:
A Multicenter, Randomized, Investigator-Blinded, Phase 2, Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3 regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis.
This is a multicenter, randomized, investigator-blinded, phase 2, dose ranging study of GW05
vaginal gel administered in 3 regimens compared to metronidazole 0.75% (QD x 5 days) for the
treatment of bacterial vaginosis. Subjects will be evaluated at three timepoints (1
screening/baseline visit, post-treatment phone call and 1 test-of-cure visit). The total
study duration may be up to 30 days for a subject.
Study medication will be applied intravaginally once daily at bedtime according to the
assigned dosing schedule using the supplied 5-gram vaginal applicators.
Investigator blinding will be ensured by utilizing an independent drug dispensing
coordinator at each site.
Bacterial vaginosis (BV) is an infection of the vagina (birth canal) that is the result of
an overgrowth of bacteria that are often normally found in the vagina. This type of vaginal
infection typically does not cause irritation. The most common complaint of patients who
suffer from BV is a fishy-smelling vaginal discharge. The amount of vaginal discharge may or
may not be increased above a normal discharge. The bad odor may get worse after sexual
intercourse or during the menstrual period. BV is also strongly associated with problems
during pregnancy, such as premature (early) birth, and with an increased risk of sexually
transmitted diseases. Therefore, it is important to treat the infection.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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