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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02863536
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : May 17, 2018
Opera Contract Research Organization SRL
Information provided by (Responsible Party):
Effik Italia S.p.A.

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Device: Polybactum® Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

Arm Intervention/treatment

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.

Primary Outcome Measures :
  1. Amsel criteria laboratory diagnostic [ Time Frame: 3 months ]
    Signs and symptoms of Bacterial Vaginosis assesed also by patients diary (vaginal discharge, burning, erythema, dyspareunia)

Secondary Outcome Measures :
  1. Lactobacilli counting [ Time Frame: 3 months ]
    The rate of return to normality of vaginal microflora through Lactobacilli counting

Other Outcome Measures:
  1. Patient's diary [ Time Frame: 3 months ]
    Global Assessment of Efficacy by Patient's diary

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02863536

Contact: Barattini Dionisio, MD +40 774 012684
Contact: Serban Rosu, MD 040722313224

Opera Contract Research Organization Srl Recruiting
Timisoara, Timis, Romania, 300209
Contact: Ramona Petrita    040721893630   
Sponsors and Collaborators
Effik Italia S.p.A.
Opera Contract Research Organization SRL
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)


Responsible Party: Effik Italia S.p.A. Identifier: NCT02863536     History of Changes
Other Study ID Numbers: OPEFF/0116/MD
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Effik Italia S.p.A.:
Recurrence of Bacterial Vaginosis

Additional relevant MeSH terms:
Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections