NCT00510614

Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	tinidazole	1 gram twice weekly for 12 weeks
DRUG	Placebo	one pill twice weekly for 12 weeks

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2007-08-02
• Last updated: 2011-02-18

Locations

1 site across 1 country: United States