Bacterial Vaginosis Clinical Trial
— POLARISOfficial 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
Verified date | September 2019 |
Source | Effik Italia S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 56 |
Est. completion date | September 21, 2018 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Romania | Opera Contract Research Organization Srl | Timisoara | Timis |
Lead Sponsor | Collaborator |
---|---|
Effik Italia S.p.A. | Opera CRO, a TIGERMED Group Company |
Romania,
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. Epub 2006 Apr 26. — View 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. Review. — View Citation
Donders GG. Definition and classification of abnormal vaginal flora. Best Pract Res Clin Obstet Gynaecol. 2007 Jun;21(3):355-73. Epub 2007 Apr 16. Review. — View 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. Review. — View 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. — View 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. Review. — View Citation
Pirotta M, Fethers KA, Bradshaw CS. Bacterial vaginosis - More questions than answers. Aust Fam Physician. 2009 Jun;38(6):394-7. — View Citation
Schwebke JR. Bacterial vaginosis--more questions than answers. Genitourin Med. 1997 Oct;73(5):333-4. — View 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. Review. — View Citation
Sobel JD. Antibiotic consideration in bacterial vaginosis. Curr Infect Dis Rep. 2009 Nov;11(6):471-5. — View 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. — View 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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient's diary | Global Assessment of Efficacy by Patient's diary | 3 months | |
Primary | Amsel criteria laboratory diagnostic | Signs and symptoms of Bacterial Vaginosis assesed also by patients diary (vaginal discharge, burning, erythema, dyspareunia) | 3 months | |
Secondary | Lactobacilli counting | The rate of return to normality of vaginal microflora through Lactobacilli counting | 3 months |
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