Bacterial vaginosis MedDRA version: 9.1 Level: LLT Classification code 10004055 Term: Bacterial vaginosis
Conditions
Interventions
Trade Name: Rifax Merckle Tabletten & Rifaxan Merckle Tabletten
Product Name: Rifaximin
Pharmaceutical Form: Vaginal tablet
INN or Proposed INN: Rifaximin
CAS Number: 8061-81-4
Concentration unit: mg
Sponsors
Alfa Wassermann S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study is to evaluate the efficacy and tolerability of two doses (100 mg and 25 mg) of rifaximin vaginal tablets vs. placebo in the treatment of bacterial vaginosis, administered either as 100 mg x 5 days or 25 mg x 5 days or 100 mg x 2 days vs. placebo to 112 female patients affected by bacterial vaginosis.;Secondary Objective: - Remission evaluated by Amsel’s criteria - Remission evaluated by Gram stain Nugent score - Maintenance of remission evaluated by Amsel’s criteria and Gram stain Nugent score at 28-35 days from the end of treatment - Local objective and subjective tolerability to the test drug - 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 after 7-10 days from the end of therapy. In particular: • remission according to Amsel’s criteria: resolution of the clinical findings assessed at baseline and • remission according to Gram stain Nugent score: score from 0 to 3. | — |
Countries
Belgium, Germany, Italy
Outcome results
None listed