NCT02376972

Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of Rifaximin Vaginal Tablets in the Treatment of Bacterial Vaginosis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: Alfasigma S.p.A. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

THE STUDY HAS BEEN DESIGNED TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS

Detailed description

THIS IS A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY PLANNING TO ENROL 626 SUBJECTS AFFECTED BY BACTERIAL VAGINOSIS. PRIMARY ENDPOINT: TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS PLACEBO IN SUBJECTS WITH BACTERIAL VAGINOSIS SECONDARY ENDPOINT: TO COMPARE THE EFFICACY OF TWO DOSES (25 MG AND 100 MG) OF RIFAXIMIN VAGINAL TABLETS VERSUS METROGEL VAGINAL IN SUBJECTS WITH BACTERIAL VAGINOSIS.

Conditions

• BACTERIAL VAGINOSIS

Interventions

Type	Name	Description
DRUG	RIFAXIMIN VAGINAL TABLET 25 MG	RIFAXIMIN VAGINAL TABLET 25 MG O.D./5 DAYS INTRAVAGINALLY
DRUG	RIFAXIMIN VAGINAL TABLET 100 MG	RIFAXIMIN VAGINAL TABLET 100 MG O.D./5 DAYS INTRAVAGINALLY
DRUG	PLACEBO VAGINAL TABLET	PLACEBO VAGINAL TABLET O.D./5 DAYS INTRAVAGINALLY
DRUG	METROGEL VAGINAL	METROGEL VAGINAL O.D./5 DAYS INTRAVAGINALLY

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-03-03
• Last updated: 2016-10-10

Locations

1 site across 1 country: United States