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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vaginosis, Bacterial

Intervention / Treatment
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* Device: Vaginal ring releasing lactic acid (racemic mixture)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vaginal Ring<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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