NCT02314429
Completed
Phase 1
Phase I Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis
ConditionsVaginosis, Bacterial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Vaginosis, Bacterial
- Sponsor
- University Ghent
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Time Frame: 7 days after insertion
Secondary Outcomes
- Assessment of vaginal pH(each 30 minutes for 4 hours after insertion, and then each 60 minutes for the next 4 hours)
Study Sites (1)
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