drugset / Trial / NCT00229216

Treatment of Bacterial Vaginosis With Oral Tinidazole

NCT00229216 ↗

Phase 3 Completed 200 enrolled Mission Pharmacal
RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start
2005-01
Primary completion
2007-06
Completion
2007-06

Outcome

Met primary endpoint

paper Superior efficacy was demonstrated by tinidazole for the 1 g once daily for 5 days regimen (36.8% cured, P<.001 PMID 17666604 ↗

paper and for the 2 g once daily for 2 days regimen (27.4% cured, P<.001, number needed to treat 4.5), when compared with placebo (5.1% cured) in the primary endpoint analysis. PMID 17666604 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject tinidazole Small molecule 1 g Oral
Subject tinidazole Small molecule 2 g Oral

Indications