Clinical trial NCT02863536: A Study of the New Medical Device Polybactum®
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginosis
Keywords: Recurrence of Bacterial Vaginosis
Lead sponsor: Effik Italia S.p.A.
Sponsor class: OTHER
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2016-08-11
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Amsel criteria laboratory diagnostic
timeFrame: 3 months
Secondary outcomes:
measure: Lactobacilli counting
timeFrame: 3 months
Other outcomes:
measure: Patient's diary
timeFrame: 3 months
Locations:
city: Timisoara
country: Romania
facility: Opera Contract Research Organization Srl
state: Timis
Study officials:
affiliation: Servizio di Patologia del Tratto Genitale Inferiore U.O. Ostetricia e Ginecologia Ospedale Vittore Buzzi - Universita' degli Studi di Milano Milano (Italy)
name: Filippo Murina, Prof.dr.
role: PRINCIPAL_INVESTIGATOR
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