A Study of the New Medical Device Polybactum®

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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A Multicenter, Open Label, Non-comparative, 3 Months Study to Assess the Performance and Safety of the New Medical Device Polybactum® in Reducing the Frequency of Recurrent Bacterial Vaginosis

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Device: Polybactum®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Polybactum®<br>Polybactum® ovules are administered intravaginally on 3 cycles, 1 cycle per month. Polybactum is a medical device Class IIa used and marketed for the recurrence of Bacterial Vaginosis. | Device: Polybactum®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amsel criteria laboratory diagnostic | Signs and symptoms of Bacterial Vaginosis assesed also by patients diary (vaginal discharge, burning, erythema, dyspareunia) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactobacilli counting | The rate of return to normality of vaginal microflora through Lactobacilli counting | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrence of Bacterial Vaginosis