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

Vaginosis, Bacterial Clinical Trial

— LACRING01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314429
• Other study ID #: EC 2013/088
• Secondary ID: 2013-001120-19
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2014
• Last updated: March 11, 2016
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: March 2016
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Device:
• Vaginal ring releasing lactic acid (racemic mixture)

Locations

Country	Name	City	State
Belgium	Department of Obstetrics & Gynaecology, Ghent University Hospital P4	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy		1 hour after insertion	Yes
Primary	Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy		2 hours after insertion	Yes
Primary	Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy		4 hours after insertion	Yes
Primary	Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy		8 hours after insertion	Yes
Primary	Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy		24 hours after insertion	Yes
Primary	Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy		7 days after insertion	Yes
Secondary	Assessment of vaginal pH		each 30 minutes for 4 hours after insertion, and then each 60 minutes for the next 4 hours	Yes