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

Phase 1

Completed

• Conditions: Vaginosis, Bacterial
• Interventions: Device: Vaginal ring releasing lactic acid (racemic mixture)

• Registration Number: NCT02314429
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-11
• Primary Completion: 2015-01
• Study Completion: 2015-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaginal Ring	Vaginal ring releasing lactic acid (racemic mixture)	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.

Primary Outcome Measures

Name	Time	Method
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy	7 days after insertion

Secondary Outcome Measures

Name	Time	Method
Assessment of vaginal pH	each 30 minutes for 4 hours after insertion, and then each 60 minutes for the next 4 hours

Trial Locations

Locations (1)

Department of Obstetrics & Gynaecology, Ghent University Hospital P4; 🇧🇪 Ghent, Belgium