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

Effik

Status: Completed

Conditions: Bacterial Vaginosis

Treatments: Device: Polybactum®

Study type: Interventional

Funder types: Other

Identifiers

NCT02863536

OPEFF/0116/MD

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women above 18 years.
• BV diagnosed by Amsel criteria (see Annex 3) in the 6-9 days before study, and cured with metronidazole vaginal formulation (gel for 5 days or ovules for 7 days).
• Diagnosis of RBV (at least 2 episodes of BV in the last 12 months including the BV cured before baseline).
• Non lactating women or lactating non amenorrheic women.
• Read and signed informed consent.

Exclusion criteria

• Pregnancy.
• Candidiasis or mixed vaginitis.
• HIV or other immunodeficiency.
• Known allergy to metronidazole or to Polybactum® ingredients.
• Sex workers.
• Menstruation or pre-menopause/menopause.
• Patients concomitantly included in different interventional clinical trials.
• Unwillingness to provide the informed consent to the trial.
• Time between the last day of last menses and baseline visit > 16 days or ≤5 days.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

56 participants in 1 patient group

Polybactum®

Other group

Description:

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.

Treatment:

Device: Polybactum®