A Study of the New Medical Device Polybactum® (POLARIS)

September 30, 2019 updated by: Effik Italia S.p.A.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Timis
      • Timisoara, Timis, Romania, 300209
        • Opera Contract Research Organization SRL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Polybactum®

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®
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amsel criteria laboratory diagnostic
Time Frame: 3 months
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
Time Frame: 3 months
The rate of return to normality of vaginal microflora through Lactobacilli counting
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's diary
Time Frame: 3 months
Global Assessment of Efficacy by Patient's diary
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Effik Italia S.p.A.

Collaborators

Opera CRO, a TIGERMED Group Company

Investigators

  • Principal Investigator: Filippo Murina, Prof.dr., Servizio di Patologia del Tratto Genitale Inferiore U.O. Ostetricia e Ginecologia Ospedale Vittore Buzzi - Universita' degli Studi di Milano Milano (Italy)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2016

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

September 21, 2018

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 8, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

October 2, 2019

Last Update Submitted That Met QC Criteria

September 30, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPEFF/0116/MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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