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Lcr35® for Bacterial Vaginosis Prevention

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Laboratoires Lyocentre
ClinicalTrials.gov Identifier:
NCT01160796
First received: July 9, 2010
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

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 ] [ Designated as safety issue: Yes ]

Enrollment: 352
Study Start Date: June 2010
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160796

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

No publications provided

Responsible Party: Laboratoires Lyocentre
ClinicalTrials.gov Identifier: NCT01160796     History of Changes
Other Study ID Numbers: PREVA
Study First Received: July 9, 2010
Last Updated: September 24, 2014
Health Authority: France: Institutional Ethical Commitee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Vaginosis, Bacterial
Bacterial Infections
Genital Diseases, Female
Vaginal Diseases
Vaginitis

ClinicalTrials.gov processed this record on November 25, 2014