A phase II, multicentre, double-blind, randomised, placebo-controlled study on efficacy and tolerability of Rifaximin vaginal tablets in the treatment of bacterial vaginosis - ND

Conditions: MedDRA version: 9.1Level: LLTClassification code 10046960Term: Vaginosis bacterial
Bacterial Vaginosis

Registration Number: EUCTR2009-011826-32-IT

Lead Sponsor: ALFA WASSERMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 112

Inclusion Criteria

Post-menarchal, pre-menopausal female patient
Non-pregnant (negative urine pregnancy test at screening and randomisation) nor breast-feeding patient
Patient aged between 18 - 50 years, inclusively
Clinical diagnosis of bacterial vaginosis with Amsel?s criteria (at least 3 of 4 fulfilled criteria
Diagnosis of bacterial vaginosis confirmed by Gram stain Nugent score (score ≥ 4)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Virginity
Patient with severe hepatic insufficiency (Child C)
Patients with severe cardiac insufficiency (NYHA ? New York Hearth Association classes 3 - 4)
Presence of vaginal infection due to STDs (Chlamidia trachomatis, Neisseria Gonorrhoeae, Trichomonas vaginalis, active Herpes Simplex lesions, Human Papilloma Virus lesions)
Vulvo-vaginal infections other than bacterial vaginosis (e.g. Candida Albicans infection)
Vulvo-vaginal or cervical abnormalities or disorders (including total hysterectomy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy and the tolerability of two doses (100 mg and 25 mg) of rifaximin vaginal tablets vs. placebo in the treatment of bacterial vaginosis;Secondary Objective: Remission evaluated by Amsel?s criteria<br>Remission evaluated by Gram stain Nugent score<br>Maintenance of remission evaluated by Amsel?s criteria and Gram stain Nugent score at 28-35 days from the end of treatment<br>Local objective and subjective tolerability to the test drug<br>Evaluation of the composition of the vaginal microbiota using PCR-DGGE and real-time PCR;Primary end point(s): Remission evaluated by Amsel?s criteria and Gram stain Nugent score at 7-10 days from the end of treatment

Secondary Outcome Measures