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

Primary Purpose

Bacterial Vaginosis

Status
Completed
Phase
Not Applicable
Locations
Romania
Study Type
Interventional
Intervention
Polybactum®
Sponsored by
Effik Italia S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Vaginosis focused on measuring Recurrence of Bacterial Vaginosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Opera Contract Research Organization Srl

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Polybactum®

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2016
Last Updated
September 30, 2019
Sponsor
Effik Italia S.p.A.
Collaborators
Opera CRO, a TIGERMED Group Company
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1. Study Identification

Unique Protocol Identification Number
NCT02863536
Brief Title
A Study of the New Medical Device Polybactum®
Acronym
POLARIS
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 Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 8, 2016 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
September 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Effik Italia S.p.A.
Collaborators
Opera CRO, a TIGERMED Group Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis
Keywords
Recurrence of Bacterial Vaginosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polybactum®
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Polybactum®
Intervention Description
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 Measure Information:
Title
Amsel criteria laboratory diagnostic
Description
Signs and symptoms of Bacterial Vaginosis assesed also by patients diary (vaginal discharge, burning, erythema, dyspareunia)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Lactobacilli counting
Description
The rate of return to normality of vaginal microflora through Lactobacilli counting
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Patient's diary
Description
Global Assessment of Efficacy by Patient's diary
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Filippo Murina, Prof.dr.
Organizational Affiliation
Servizio di Patologia del Tratto Genitale Inferiore U.O. Ostetricia e Ginecologia Ospedale Vittore Buzzi - Universita' degli Studi di Milano Milano (Italy)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Opera Contract Research Organization Srl
City
Timisoara
State/Province
Timis
ZIP/Postal Code
300209
Country
Romania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9534738
Citation
Schwebke JR. Bacterial vaginosis--more questions than answers. Genitourin Med. 1997 Oct;73(5):333-4. doi: 10.1136/sti.73.5.333. No abstract available.
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Citation
Sobel JD. Antibiotic consideration in bacterial vaginosis. Curr Infect Dis Rep. 2009 Nov;11(6):471-5. doi: 10.1007/s11908-009-0068-5.
Results Reference
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PubMed Identifier
21524714
Citation
Marrazzo JM. Interpreting the epidemiology and natural history of bacterial vaginosis: are we still confused? Anaerobe. 2011 Aug;17(4):186-90. doi: 10.1016/j.anaerobe.2011.03.016. Epub 2011 Apr 16.
Results Reference
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PubMed Identifier
16652274
Citation
Bradshaw CS, Morton AN, Hocking J, Garland SM, Morris MB, Moss LM, Horvath LB, Kuzevska I, Fairley CK. High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence. J Infect Dis. 2006 Jun 1;193(11):1478-86. doi: 10.1086/503780. Epub 2006 Apr 26.
Results Reference
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PubMed Identifier
17434799
Citation
Donders GG. Definition and classification of abnormal vaginal flora. Best Pract Res Clin Obstet Gynaecol. 2007 Jun;21(3):355-73. doi: 10.1016/j.bpobgyn.2007.01.002. Epub 2007 Apr 16.
Results Reference
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PubMed Identifier
24294744
Citation
Kovachev S, Dobrevski-Vacheva R. [Probiotic monotherapy of bacterial vaginosis: a open, randomized trial]. Akush Ginekol (Sofiia). 2013;52 Suppl 1:36-42. Bulgarian.
Results Reference
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PubMed Identifier
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Citation
Falagas M, Betsi GI, Athanasiou S. Probiotics for the treatment of women with bacterial vaginosis. Clin Microbiol Infect. 2007 Jul;13(7):657-64. doi: 10.1111/j.1469-0691.2007.01688.x.
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PubMed Identifier
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Citation
Vujic G, Jajac Knez A, Despot Stefanovic V, Kuzmic Vrbanovic V. Efficacy of orally applied probiotic capsules for bacterial vaginosis and other vaginal infections: a double-blind, randomized, placebo-controlled study. Eur J Obstet Gynecol Reprod Biol. 2013 May;168(1):75-9. doi: 10.1016/j.ejogrb.2012.12.031. Epub 2013 Feb 7.
Results Reference
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PubMed Identifier
16260520
Citation
Swidsinski A, Mendling W, Loening-Baucke V, Ladhoff A, Swidsinski S, Hale LP, Lochs H. Adherent biofilms in bacterial vaginosis. Obstet Gynecol. 2005 Nov;106(5 Pt 1):1013-23. doi: 10.1097/01.AOG.0000183594.45524.d2.
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PubMed Identifier
19821358
Citation
Senok AC, Verstraelen H, Temmerman M, Botta GA. Probiotics for the treatment of bacterial vaginosis. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD006289. doi: 10.1002/14651858.CD006289.pub2.
Results Reference
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PubMed Identifier
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Citation
Brown P, Brunnhuber K, Chalkidou K, Chalmers I, Clarke M, Fenton M, Forbes C, Glanville J, Hicks NJ, Moody J, Twaddle S, Timimi H, Young P. How to formulate research recommendations. BMJ. 2006 Oct 14;333(7572):804-6. doi: 10.1136/bmj.38987.492014.94.
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Citation
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Results Reference
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A Study of the New Medical Device Polybactum®

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