MedTrace Logo

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

NCT02314429 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-03-14

No results posted yet for this study

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.

Conditions

  • Vaginosis, Bacterial

Interventions

DEVICE

Vaginal ring releasing lactic acid (racemic mixture)

Sponsors & Collaborators

  • University Ghent

    lead OTHER

Principal Investigators

  • Hans Verstraelen, Prof. dr. · University & University Hospital Ghent

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-01-31
Completion
2015-09-30

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02314429 on ClinicalTrials.gov