LACRING01: Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis

• Sponsor: University Ghent (Other)
• Overall Status: Completed
• CT.gov ID: NCT02314429
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginosis, Bacterial	Device: Vaginal ring releasing lactic acid (racemic mixture)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Phase I Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis
• Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vaginal Ring 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)

Outcome Measures

Primary Outcome Measures

1. Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy [1 hour after insertion]

2. Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy [2 hours after insertion]

3. Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy [4 hours after insertion]

4. Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy [8 hours after insertion]

5. Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy [24 hours after insertion]

6. Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy [7 days after insertion]

Secondary Outcome Measures

1. Assessment of vaginal pH [each 30 minutes for 4 hours after insertion, and then each 60 minutes for the next 4 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Obstetrics & Gynaecology, Ghent University Hospital P4	Ghent		Belgium	9000

Sponsors and Collaborators

• University Ghent

Investigators

• Principal Investigator: Hans Verstraelen, Prof. dr., University & University Hospital Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Ghent
• ClinicalTrials.gov Identifier: NCT02314429
• Other Study ID Numbers: EC 2013/088; 2013-001120-19
• First Posted: Dec 11, 2014
• Last Update Posted: Mar 14, 2016
• Last Verified: Mar 1, 2016

• Additional relevant MeSH terms: Vaginosis, Bacterial; Vaginal Diseases

Study Results

No Results Posted as of Mar 14, 2016