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

University Ghent1 site in 1 country6 target enrollmentStarted: September 1, 2014Last updated: March 14, 2016

Conditions

Interventions

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: University Ghent
Enrollment: 6
Locations: 1
Primary Endpoint: Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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 Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Masking: None

Eligibility Criteria

Ages: 18 Years to 45 Years (Adult)
Sex: Female
Accepts Healthy Volunteers: Yes

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

Arms & Interventions

Vaginal Ring

Experimental

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.

Intervention: Vaginal ring releasing lactic acid (racemic mixture) (Device)