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Lcr35® for Bacterial Vaginosis Prevention

This study has been completed.
Information provided by (Responsible Party):
Laboratoires Lyocentre Identifier:
First received: July 9, 2010
Last updated: March 24, 2016
Last verified: March 2016

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®).

Condition Intervention Phase
Bacterial Vaginosis Drug: placebo Drug: Lcr35® Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Laboratoires Lyocentre:

Primary Outcome Measures:
  • mean time before the onset of first clinical recurrence confirmed by laboratory tests [ Time Frame: 4 months ]

Enrollment: 352
Study Start Date: June 2010
Study Completion Date: April 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lcr35® Drug: Lcr35®
1x14-day course of treatment during 4 cycles
Placebo Comparator: placebo Drug: placebo
1x14-day course of treatment during 4 cycles


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient presenting with a symptomatic vaginosis characterised by the presence of the following 3 clinical criteria (among the 4 Amsel criteria) at V1:

    • greyish uniform vaginal discharge,
    • characteristic "rotten fish" smell caused by the spontaneous release of amine or during the potassium test or "sniff test",
    • vaginal pH greater than 4.5.
  • Patient with a Nugent score ≥ 7 (using the sample taken at V1).
  • Patient clinically cured (none of the 3 Amsel criteria) after a 7-day course of Metronidazole (Flagyl®) Female.
  • Patient over 18 years of age.
  • For women with childbearing potential:

    • negative urine pregnancy test,
    • use of a contraceptive method deemed effective by the Investigator (excluding spermicides).
  • Patient having received information and voluntarily signed a written Informed Consent Form.
  • Patient covered by a national insurance scheme.

Exclusion Criteria:

  • Presence of a yeast infection that is bacterial (other than vaginosis) or viral in origin presumed or proven to be gynaecologically-linked, whether or not treated within the month preceding inclusion or present at the time of inclusion.
  • Presence of an existing gynaecological infection that may interfere with the assessment of the trial treatment(fibroma, severe dysplasia of the cervix or in situ carcinoma, invasive carcinoma, intra-epithelial cervical neoplasia, squamous intra-epithelial lesions etc.)
  • Antibiotics or antifungals taken by general route during the month preceding the screening visit, excluding treatment for an earlier episode of vaginosis.
  • Use of probiotics in the month preceding the screening visit, excluding treatment for an earlier episode of vaginosis.
  • Use of intravaginal antiseptics in the month preceding the screening visit, excluding treatment for an earlier episode of vaginosis.
  • Use of prebiotics (acidifiers) during the two weeks preceding the screening visit.
  • Use of products containing topical oestrogens during the month preceding the screening visit.
  • Allergy to one of the active ingredients or one of the excipients in the products.
  • patient in post-menopausal time
  • Patient unable to comply with the constraints of the Protocol.
  • Breastfeeding patient.
  • Patient with menstrual bleeds lasting more than 12 days a month.
  • Patient having taken part in a clinical trial in the 3 months preceding inclusion in the present Protocol.
  • Patient with a severe acute or chronic disease deemed by the Investigator to be incompatible with participation in the trial, or a serious infection that is life-threatening in the short term.
  • Immuno-suppressed patient.
  • Patient presenting with a previous illness which, according to the Investigator, is likely to interfere with the results of the trial or expose the patient to an additional risk.
  • Patient linguistically or mentally unable to understand and sign the Informed Consent Form.
  • Patient deprived of her liberty by order of the Courts or civil authorities or subject to a guardianship order.
  • Patient likely not to comply with treatment.
  • Patient unable to be contacted in the case of an emergency.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01160796

Aurillac, France, 15000
Sponsors and Collaborators
Laboratoires Lyocentre
  More Information

Responsible Party: Laboratoires Lyocentre Identifier: NCT01160796     History of Changes
Other Study ID Numbers: PREVA
Study First Received: July 9, 2010
Last Updated: March 24, 2016

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis processed this record on September 21, 2017