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Efficacy and Safety Study of Rifaximin Vaginal Tablets in Bacterial Vaginosis

NCT02376972 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 392

Last updated 2016-10-10

No results posted yet for this study

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

Conditions

  • BACTERIAL VAGINOSIS

Interventions

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

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Alfasigma S.p.A.

    lead INDUSTRY

Principal Investigators

  • Raffaella Tacchi, MD · Alfasigma S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02376972 on ClinicalTrials.gov