Bacterial Vaginosis
Conditions
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®).
Interventions
DRUGplacebo
1x14-day course of treatment during 4 cycles
DRUGLcr35®
1x14-day course of treatment during 4 cycles
Sponsors
Laboratoires Lyocentre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean time before the onset of first clinical recurrence confirmed by laboratory tests | 4 months |
Countries
France
Outcome results
None listed