NCT01160796CompletedPhase 3
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
Laboratoires Lyocentre1 site in 1 country352 target enrollmentStarted: June 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 352
- Locations
- 1
- Primary Endpoint
- mean time before the onset of first clinical recurrence confirmed by laboratory tests
Study Overview
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®).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
- •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.
Arms & Interventions
placebo
Placebo Comparator
Intervention: placebo (Drug)
Lcr35®
Experimental
Intervention: Lcr35® (Drug)
Outcomes
Primary Outcomes
mean time before the onset of first clinical recurrence confirmed by laboratory tests
Time Frame: 4 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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