Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis (LACRING01)

University Ghent

Status and phase: Completed; Phase 1

Conditions: Vaginosis, Bacterial

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02314429

2013-001120-19 (EudraCT Number)

EC 2013/088

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

6 participants in 1 patient group

Vaginal Ring

Experimental group

Description:

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.

Treatment:

Device: Vaginal ring releasing lactic acid (racemic mixture)