Lcr35® for Bacterial Vaginosis Prevention

NCT01160796 | Completed Phase 3

• 1 other identifier: PREVA
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• mean time before the onset of first clinical recurrence confirmed by laboratory tests

  4 months

Study Arms (2)

Lcr35®

EXPERIMENTAL

Drug: Lcr35®

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

placebo DRUG

1x14-day course of treatment during 4 cycles

placebo

Lcr35® DRUG

1x14-day course of treatment during 4 cycles

Lcr35®

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Laboratoires Lyocentre: lead

Study Sites (1)

Lyocentre

Aurillac, 15000, France

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 12, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: April 1, 2012
• Last Updated: March 25, 2016

Record last verified: 2016-03

Locations

FR (1)