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A Study of the New Medical Device Polybactum® — POLARIS  

Bacterial Vaginosis Clinical Trial

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

Clinical 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

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02863536
Study type Interventional
Source Effik Italia S.p.A.
Contact
Status Completed
Phase N/A
Start date September 8, 2016
Completion date September 21, 2018
View Details
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