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Lcr35® for Bacterial Vaginosis Prevention

NCT01160796 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2016-03-25

No results posted yet for this study

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®).

Conditions

  • Bacterial Vaginosis

Interventions

DRUG

placebo

1x14-day course of treatment during 4 cycles

DRUG

Lcr35®

1x14-day course of treatment during 4 cycles

Sponsors & Collaborators

  • Laboratoires Lyocentre

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-05-31
Completion
2012-04-30

Countries

  • France

Study Locations

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Entities

Drugs

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 NCT01160796 on ClinicalTrials.gov