Vaginosis, Bacterial
Conditions
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.
Interventions
DEVICEVaginal ring releasing lactic acid (racemic mixture)
Sponsors
University Ghent
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy | 1 hour after insertion |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of vaginal pH | each 30 minutes for 4 hours after insertion, and then each 60 minutes for the next 4 hours |
Countries
Belgium
Outcome results
None listed