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A Study of the New Medical Device Polybactum®

NCT02863536 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2019-10-02

No results posted yet for this study

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

Conditions

  • Bacterial Vaginosis

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Opera CRO, a TIGERMED Group Company

    collaborator OTHER

  • Effik Italia S.p.A.

    lead OTHER

Principal Investigators

  • 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)

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-08
Primary Completion
2018-08-01
Completion
2018-09-21

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02863536 on ClinicalTrials.gov