Overview

Lcr35® for Bacterial Vaginosis Prevention

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
0
Participant gender:
Female
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®).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Laboratoires Lyocentre
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.