Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study
Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
Summary
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.