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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®).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lcr35® | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | 1x14-day course of treatment during 4 cycles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| mean time before the onset of first clinical recurrence confirmed by laboratory tests | 4 months |
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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:
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:
Patient having received information and voluntarily signed a written Informed Consent Form.
Patient covered by a national insurance scheme.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lyocentre | Aurillac | 15000 | France |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| Lcr35® |
| Drug |
1x14-day course of treatment during 4 cycles |
|
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |