Status:
COMPLETED
Lcr35® for Bacterial Vaginosis Prevention
Lead Sponsor:
Laboratoires Lyocentre
Conditions:
Bacterial Vaginosis
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT01160796
Start Date
June 1 2010
End Date
April 1 2012
Last Update
March 25 2016
Active Locations (1)
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1
Lyocentre
Aurillac, France, 15000