Completed NA INTERVENTIONAL 1-arm NCT02863536

A Study of the New Medical Device Polybactum® (POLARIS)

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

Sponsor: Effik Italia S.p.A.

Conditions Bacterial Vaginosis

Interventions Polybactum®

Updated 9 times since 2017 Last updated: Sep 30, 2019 Started: Sep 8, 2016 Primary completion: Aug 1, 2018 Completion: Sep 21, 2018

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This NA trial investigates Bacterial Vaginosis and is currently completed. Effik Italia S.p.A. leads this study, which shows 9 recorded versions since 2016 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed NA
Sep 2024 — Sep 2025 [monthly]

Completed NA
Jul 2024 — Sep 2024 [monthly]

Completed NA
Jan 2021 — Jul 2024 [monthly]

Completed NA
Nov 2019 — Jan 2021 [monthly]

Completed NA

▶ Show 4 earlier versions

Oct 2019 — Nov 2019 [monthly]

Completed NA

Status: Recruiting → Completed
Apr 2019 — Oct 2019 [monthly]

Recruiting NA
Jun 2018 — Apr 2019 [monthly]

Recruiting NA

Phase: PHASE3 → NA
Jan 2017 — Jun 2018 [monthly]

Recruiting PHASE3

First recorded

Sep 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Effik Italia S.p.A.
Opera CRO, a TIGERMED Group Company

Data source: Effik Italia S.p.A.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Timișoara, Romania