Treatment of Bacterial Vaginosis With Oral Tinidazole

Phase 3

Completed

• Conditions: Bacterial Vaginosis

• Registration Number: NCT00229216
• Lead Sponsor: Mission Pharmacal

Brief Summary

The purpose of this study is to confirm the safety and efficacy of oral tinidazole for the treatment of bacterial vaginosis.

Detailed Description

Tinidazole is a second-generation nitroimidazole i.e. an updated form of the standard drug used to treat bacterial vaginosis (metronidazole). Two dosing regimens are being compared to placebo to treat bacterial vaginosis, one of the most common vaginal infections.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-27
• Study First Submitted QC: 2005-09-27
• Study First Posted: 2005-09-29
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Clinical and microbiological diagnosis of bacterial vaginosis -

Exclusion Criteria

Other sexually transmitted disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety
Therapeutic efficacy

Secondary Outcome Measures

Name	Time	Method
Clinical efficacy
Microbiological efficacy

Trial Locations

Locations (1)

Duke University School of Medicine; 🇺🇸 Durham, North Carolina, United States