NCT02863536

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

September 8, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2018

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

1.9 years

First QC Date

August 1, 2016

Last Update Submit

September 30, 2019

Conditions

Bacterial Vaginosis

Keywords

Recurrence of Bacterial Vaginosis

Outcome Measures

Primary Outcomes (1)

  • Amsel criteria laboratory diagnostic

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

    3 months

Secondary Outcomes (1)

  • Lactobacilli counting

    3 months

Other Outcomes (1)

  • Patient's diary

    3 months

Study Arms (1)

Polybactum®

OTHER

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®

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.

Polybactum®

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Opera Contract Research Organization Srl

Timișoara, Timiș County, 300209, Romania

Location

Related Publications (13)

  • 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.

    PMID: 9534738BACKGROUND

  • Sobel JD. Antibiotic consideration in bacterial vaginosis. Curr Infect Dis Rep. 2009 Nov;11(6):471-5. doi: 10.1007/s11908-009-0068-5.

    PMID: 19857387BACKGROUND

  • 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.

    PMID: 21524714BACKGROUND

  • 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.

    PMID: 16652274BACKGROUND

  • 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.

    PMID: 17434799BACKGROUND

  • Kovachev S, Dobrevski-Vacheva R. [Probiotic monotherapy of bacterial vaginosis: a open, randomized trial]. Akush Ginekol (Sofiia). 2013;52 Suppl 1:36-42. Bulgarian.

    PMID: 24294744BACKGROUND

  • 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.

    PMID: 17633390BACKGROUND

  • 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.

    PMID: 23395559BACKGROUND

  • 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.

    PMID: 16260520BACKGROUND

  • 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.

    PMID: 19821358BACKGROUND

  • 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.

    PMID: 17038740BACKGROUND

  • Pirotta M, Fethers KA, Bradshaw CS. Bacterial vaginosis - More questions than answers. Aust Fam Physician. 2009 Jun;38(6):394-7.

    PMID: 19521581BACKGROUND

  • Murina F, Inghirami P, Biris M, Sirbu D, Barattini DF, Sbrocca F, Ardolino LI, Mangrella M, Casolati E, Rosu S, Crisan CD. Performance and Safety of a New Medical Device (Polybactum) for Reducing the Recurrence Rate of Bacterial Vaginosis: Protocol for a Multicenter, Open-Label, Noncontrolled International Clinical Trial (POLARIS Study). JMIR Res Protoc. 2023 Jul 20;12:e42787. doi: 10.2196/42787.

    PMID: 37471117DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • 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)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 11, 2016

Study Start

September 8, 2016

Primary Completion

August 1, 2018

Study Completion

September 21, 2018

Last Updated

October 2, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)