At a glance
ClinicalIndex Comparison RecordN/ACompleted· 56 enrolled
Drug / intervention
Polybactum®device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Polybactum® for Bacterial Vaginosis. Completed, enrolled 56 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBacterial Vaginosis
CountriesRomania
CollaboratorsOpera CRO, a TIGERMED Group Company
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartSep 2016
Primary CompletionAug 2018
Study CompletionSep 2018
TodayJul 2026
First PostedAug 11, 2016
Enrollment StartSep 8, 2016
Primary CompletionAug 1, 2018
Study CompletionSep 21, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.9 years ago
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.