Bacterial Vaginosis Clinical Trial
Official title:
Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study
This research study is being done to evaluate the use of an oral (by mouth) medication
called tinidazole to initially treat BV and then to see if additional treatment with
tinidazole keeps women from getting this infection back within 3 months. Tinidazole is
currently approved by the United States Food and Drug Administration (FDA) to treat
bacterial vaginosis (BV).
This study will evaluate the use of tinidazole to treat a woman's current BV infection and
then will look at using tinidazole as a suppressive treatment (taking medication regularly
to attempt to decrease the "bad" bacteria from growing back). The suppressive treatment
phase will include using tinidazole twice a week compared to using placebo twice a week and
then following women for recurrence of BV. The purpose of this study is to determine if
tinidazole suppression will prevent BV from coming back within 3 months of treatment.
The investigators hypothesize that women with a history of recurrent bacterial vaginosis who
are randomized to a suppressive regimen (a dose of medication given on a regular basis to
attempt to control the bacteria that causes bacterial vaginosis) of tinidazole will have
lower recurrence rates and a longer time to recurrence of bacterial vaginosis when compared
to those women randomized to placebo.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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