A Study of the New Medical Device Polybactum®

Effik Italia S.p.A.56 enrolled

Overview

The POLARIS trial is designed as a multicenter, open label, non-comparative, 3 months, clinical study. Interventional, non-controlled, multicenter trial with a prospective design on one cohort of patients

To evaluate the efficacy of Polybactum® administered for 3 cycles (one cycle/month) in reducing the rate of recurrence of BV in women cured with vaginal metronidazole and to compare the results of the treatment with the rate of recurrence reported in appropriate selected international literature. Therefore, the Polybactum® early administration should be able to modify the basal individual risk of BV recurrence.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Bacterial Vaginosis

Interventions

Polybactum®DEVICE

3 cycles treatment one per month.. Duration of one cycle: 1 week; administration for each cycle: 1 ovule at Day 1, 1 ovule at Day 4; 1 ovule at Day 7.In the two following cycles, the same treatment will be repeated immediately after the end of the first and second menstrual bleeding.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women above 18 years. * BV diagnosed by Amsel criteria (see Annex 3) in the 6-9 days before study, and cured with metronidazole vaginal formulation (gel for 5 days or ovules for 7 days). * Diagnosis of RBV (at least 2 episodes of BV in the last 12 months including the BV cured before baseline). * Non lactating women or lactating non amenorrheic women. * Read and signed informed consent. Exclusion Criteria: * Pregnancy. * Candidiasis or mixed vaginitis. * HIV or other immunodeficiency. * Known allergy to metronidazole or to Polybactum® ingredients. * Sex workers. * Menstruation or pre-menopause/menopause. * Patients concomitantly included in different interventional clinical trials. * Unwillingness to provide the informed consent to the trial. * Time between the last day of last menses and baseline visit \> 16 days or ≤5 days.

Locations (1)

Opera Contract Research Organization Srl

Timișoara, Timiș County, Romania

Outcomes

Primary Outcomes

Amsel criteria laboratory diagnostic

Signs and symptoms of Bacterial Vaginosis assesed also by patients diary (vaginal discharge, burning, erythema, dyspareunia)

Time frame: 3 months

Secondary Outcomes

Lactobacilli counting

The rate of return to normality of vaginal microflora through Lactobacilli counting

Time frame: 3 months

Data from ClinicalTrials.gov

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