Lcr35® for Bacterial Vaginosis Prevention

Status Completed

Clinical Trial Summary

This is a national, multi-centre, randomized, double-blind placebo-controlled, phase III superiority trial.

The main objective of the trial is to assess the efficacy of Lcr35® by comparing the mean time before the onset of the first clinical recurrence confirmed by laboratory tests in patients with bacterial vaginosis treated with Lcr35® versus placebo.

Patients with bacterial vaginosis will be enroll by private gynecologists. Each patient will receive a treatment for the initial episode(Metronidazole)and a treatment to prevent the recurrence of bacterial vaginosis (Lcr35®).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01160796
Study type	Interventional
Source	Laboratoires Lyocentre
Contact
Status	Completed
Phase	Phase 3
Start date	June 2010
Completion date	April 2012

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