Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis
Phase 1
Completed
- Conditions
- Vaginosis, Bacterial
- 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
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
- 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
Department of Obstetrics & Gynaecology, Ghent University Hospital P4🇧🇪Ghent, Belgium