A Study of the New Medical Device Polybactum® (POLARIS)
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|ClinicalTrials.gov Identifier: NCT02863536|
Recruitment Status : Completed
First Posted : August 11, 2016
Last Update Posted : October 2, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Vaginosis||Device: Polybactum®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 8, 2016|
|Actual Primary Completion Date :||August 1, 2018|
|Actual Study Completion Date :||September 21, 2018|
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.
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.
- Amsel criteria laboratory diagnostic [ Time Frame: 3 months ]Signs and symptoms of Bacterial Vaginosis assesed also by patients diary (vaginal discharge, burning, erythema, dyspareunia)
- Lactobacilli counting [ Time Frame: 3 months ]The rate of return to normality of vaginal microflora through Lactobacilli counting
- Patient's diary [ Time Frame: 3 months ]Global Assessment of Efficacy by Patient's diary
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863536
|Opera Contract Research Organization Srl|
|Timisoara, Timis, Romania, 300209|
|Principal Investigator:||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)|