Bacterial VaginosisPOLARISNCT02863536
A Study of the New Medical Device Polybactum®
A study testing Polybactum® in people with Bacterial Vaginosis, run by Effik Italia S.p.A. at 1 site in Romania.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Polybactum®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteRomania
- Study dates
- 8 Sep 2016to 21 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy.
- Candidiasis or mixed vaginitis.
- HIV or other immunodeficiency.
- Known allergy to metronidazole or to Polybactum® ingredients.
- Sex workers.
- Menstruation or pre-menopause/menopause.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Romania1 site
Opera Contract Research Organization Srl
Timișoara, Timiș County, 300209
About this study
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
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
Read the 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.
- Conditions
- Bacterial Vaginosis
- Being tested
- Polybactum®
- Keywords
- Recurrence of Bacterial Vaginosis
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Polybactum® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amsel criteria laboratory diagnostic
Signs and symptoms of Bacterial Vaginosis assesed also by patients diary (vaginal discharge, burning, erythema, dyspareunia)
Measured: 3 months
Secondary outcomes (1)
Lactobacilli counting
The rate of return to normality of vaginal microflora through Lactobacilli counting
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start8 Sep 2016
- Primary completion1 Aug 2018
- Study completion21 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Effik Italia S.p.A.
- Sponsor type
- University, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- Filippo Murina, Prof.dr., Principal investigator, Servizio di Patologia del Tratto Genitale Inferiore U.O. Ostetricia e Ginecologia Ospedale Vittore Buzzi - Universita' degli Studi di Milano Milano (Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863536
- Sponsor's protocol ID
- OPEFF/0116/MD
- Acronym
- POLARIS
- Status last verified
- Sep 2019
- First submitted
- 1 Aug 2016
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 9534738Sobel JD. Antibiotic consideration in bacterial vaginosis. Curr Infect Dis Rep. 2009 Nov;11(6):471-5. doi: 10.1007/s11908-009-0068-5.
PubMed 19857387Marrazzo 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.
PubMed 21524714Bradshaw 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.
PubMed 16652274Donders 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.
PubMed 17434799Kovachev S, Dobrevski-Vacheva R. [Probiotic monotherapy of bacterial vaginosis: a open, randomized trial]. Akush Ginekol (Sofiia). 2013;52 Suppl 1:36-42. Bulgarian.
PubMed 24294744Falagas 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.
PubMed 17633390Vujic 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.
PubMed 23395559Swidsinski 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.
PubMed 16260520Senok 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.
PubMed 19821358Brown 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.
PubMed 17038740Pirotta M, Fethers KA, Bradshaw CS. Bacterial vaginosis - More questions than answers. Aust Fam Physician. 2009 Jun;38(6):394-7.
PubMed 19521581Murina 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.
PubMed 37471117
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02863536
- Acronym / sponsor ID
- POLARIS / OPEFF/0116/MD
- Conditions
- Bacterial Vaginosis
- Keywords
- Recurrence of Bacterial Vaginosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Effik Italia S.p.A.University, hospital or other
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 8 Sep 2016 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polybactum® | Other | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- Pregnancy.
- Candidiasis or mixed vaginitis.
- HIV or other immunodeficiency.
- Known allergy to metronidazole or to Polybactum® ingredients.
- Sex workers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Polybactum® |
Primary outcome
Amsel criteria laboratory diagnostic
Time frame: 3 months
Signs and symptoms of Bacterial Vaginosis assesed also by patients diary (vaginal discharge, burning, erythema, dyspareunia)
1 secondary outcome
Lactobacilli counting
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Background: PubMed 9534738Schwebke 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.
- Background: PubMed 19857387Sobel JD. Antibiotic consideration in bacterial vaginosis. Curr Infect Dis Rep. 2009 Nov;11(6):471-5. doi: 10.1007/s11908-009-0068-5.
- Background: PubMed 21524714Marrazzo 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.
- Background: PubMed 16652274Bradshaw 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.
- Background: PubMed 17434799Donders 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.
- Background: PubMed 24294744Kovachev S, Dobrevski-Vacheva R. [Probiotic monotherapy of bacterial vaginosis: a open, randomized trial]. Akush Ginekol (Sofiia). 2013;52 Suppl 1:36-42. Bulgarian.
- Background: PubMed 17633390Falagas 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.
- Background: PubMed 23395559Vujic 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.
- Background: PubMed 16260520Swidsinski 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.
- Background: PubMed 19821358Senok 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.
- Background: PubMed 17038740Brown 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.
- Background: PubMed 19521581Pirotta M, Fethers KA, Bradshaw CS. Bacterial vaginosis - More questions than answers. Aust Fam Physician. 2009 Jun;38(6):394-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filippo Murina, Prof.dr. principal investigator
Servizio di Patologia del Tratto Genitale Inferiore U.O. Ostetricia e Ginecologia Ospedale Vittore Buzzi - Universita' degli Studi di Milano Milano (Italy)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polybactum® in people with Bacterial Vaginosis, run by Effik Italia S.p.A. at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amsel criteria laboratory diagnostic (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02863536, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.