NCT01160796

Lcr35® for Bacterial Vaginosis Prevention

Study of the Efficacy and Safety of Treatment With Total Freeze-dried Culture of Lactobacillus Casei Var. Rhamnosus (Lcr35®) Administered Intravaginally in the Prevention of Bacterial Vaginosis. Randomized, Phase III, Multi-centre, Double-blind, Placebo-controlled Superiority Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 352 (actual)
• Sponsor: Laboratoires Lyocentre · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	placebo	1x14-day course of treatment during 4 cycles
DRUG	Lcr35®	1x14-day course of treatment during 4 cycles

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-05-01
• Completion: 2012-04-01
• First posted: 2010-07-12
• Last updated: 2016-03-25

Locations

1 site across 1 country: France