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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 112

Inclusion Criteria

• Caucasian race
• 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
• Patient who is willing to be asked questions about personal medical health and sexual history
• Patient capable of and willing to conform to the study protocol
• Patient who have been thoroughly informed of the aim of the study and the study procedures and who provided signed and dated written informed consent form
• Patient who agrees to abstain from intercourse during 5-day treatment period
• Patient who agrees also to abstain from intercourse 3 days before the scheduled visits of follow-up
• Patient who agrees to abstain from the use of any other intravaginal product (i.e. douching, feminine deodorants sprays, tampons, spermicides, gels, foams, and diaphragms) during the entire study period
• Patient who agrees to use an adequate method of birth control for the duration of the study to avoid pregnancy. Acceptable methods include a history of bilateral tubaric ligature, male partner with a vasectomy, a steroidal contraceptive (oral, patch, injectable or implantable), IUD or abstinence
• 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) yes
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)
• Positive Papanicolau test for all degree of cervical neoplastic disease (atypical cells, intraepithelial lesions, in situ lesions, carcinoma), or inadequate sample
• Any condition or circumstance that would prevent completion of the study or interfere with analysis of study results, including a history of drug or alcohol abuse, mental illness or non-compliance with treatments or visits, with immunological (including HIV infection), haematological or neoplastic disease (including all cervical neoplastic diseases)
• Cervical cryotherapy or cervical laser within the last 3 months
• Patient with clinically relevant pathological laboratory values
• Known hypersensitivity to rifaximin
• Known hypersensitivity to drug formulation
• Menstruating at screening and during the drug administration
• Antifungal or antimicrobial treatment within 14 days prior to the screening visit
• 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)
• Symptoms suggestive of pelvic inflammatory disease
• Withdrawal of informed consent
• Patient who have used any investigational drug within 6 months prior to screening visit
• Patient who have donated 250 ml or more of blood in the last 3 months prior to screening visit

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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