Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis

University Ghent6 enrolled

Overview

In this first-in-human volunteer phase I clinical trial, a vaginal ring that slowly releases lactic acid (racemic mixture) into the vaginal environment, will be inserted in healthy volunteering women and left in place for 7 days. The primary objective of this phase I study is to assess the safety and the tolerability of this new intravaginal delivery system. The eventual goal of this and related studies is to develop a vaginal ring that reduces recurrences in women suffering from bacterial vaginosis, which is the commonest form of vaginal infection.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Vaginosis, Bacterial

Interventions

Vaginal ring releasing lactic acid (racemic mixture)DEVICE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Good general physical and mental health * Presence of normal (lactobacilli-dominated) vaginal microbiota * Prepared to take oral contraception during the study Exclusion Criteria: * Pregnancy * Lactation * Systemic disease * Menopause * Recent use of antibiotics (\<1 week before entering the study) * Recent use of intravaginal products or devices (\<1 week before enrolment) * Presence of vaginal infection

Locations (1)

Department of Obstetrics & Gynaecology, Ghent University Hospital P4

Ghent, Belgium