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

March 11, 2016 updated by: University Ghent

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Department of Obstetrics & Gynaecology, Ghent University Hospital P4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaginal Ring
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.
Device: Vaginal ring releasing lactic acid (racemic mixture)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Time Frame: 1 hour after insertion
1 hour after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Time Frame: 2 hours after insertion
2 hours after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Time Frame: 4 hours after insertion
4 hours after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Time Frame: 8 hours after insertion
8 hours after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Time Frame: 24 hours after insertion
24 hours after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Time Frame: 7 days after insertion
7 days after insertion

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of vaginal pH
Time Frame: each 30 minutes for 4 hours after insertion, and then each 60 minutes for the next 4 hours
each 30 minutes for 4 hours after insertion, and then each 60 minutes for the next 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Investigators

  • Principal Investigator: Hans Verstraelen, Prof. dr., University & University Hospital Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

December 2, 2014

First Submitted That Met QC Criteria

December 10, 2014

First Posted (Estimate)

December 11, 2014

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC 2013/088
  • 2013-001120-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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