Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2016-09-08
2018-09-21
Brief Summary
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Interventional, non-controlled, multicenter trial with a prospective design on one cohort of patients
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Opera CRO, a TIGERMED Group Company
OTHER
Effik Italia S.p.A.
OTHER
Responsible Party
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Principal Investigators
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Filippo Murina, Prof.dr.
Role: PRINCIPAL_INVESTIGATOR
Servizio di Patologia del Tratto Genitale Inferiore U.O. Ostetricia e Ginecologia Ospedale Vittore Buzzi - Universita' degli Studi di Milano Milano (Italy)
Locations
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Opera Contract Research Organization Srl
Timișoara, Timiș County, Romania
Countries
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References
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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.
Sobel JD. Antibiotic consideration in bacterial vaginosis. Curr Infect Dis Rep. 2009 Nov;11(6):471-5. doi: 10.1007/s11908-009-0068-5.
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.
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.
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.
Kovachev S, Dobrevski-Vacheva R. [Probiotic monotherapy of bacterial vaginosis: a open, randomized trial]. Akush Ginekol (Sofiia). 2013;52 Suppl 1:36-42. Bulgarian.
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.
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.
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.
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.
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.
Pirotta M, Fethers KA, Bradshaw CS. Bacterial vaginosis - More questions than answers. Aust Fam Physician. 2009 Jun;38(6):394-7.
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.
Other Identifiers
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OPEFF/0116/MD
Identifier Type: -
Identifier Source: org_study_id
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