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

NCT ID: NCT02314429

Last Updated: 2016-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-09-30

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.

Conditions

Vaginosis, Bacterial

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vaginal ring releasing lactic acid (racemic mixture)

Intervention Type: DEVICE

Interventions

Vaginal ring releasing lactic acid (racemic mixture)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans Verstraelen, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

University & University Hospital Ghent

Locations

Department of Obstetrics & Gynaecology, Ghent University Hospital P4

Ghent, , Belgium

Countries

Belgium

References

Verstraelen H, Vervaet C, Remon JP. Rationale and Safety Assessment of a Novel Intravaginal Drug-Delivery System with Sustained DL-Lactic Acid Release, Intended for Long-Term Protection of the Vaginal Microbiome. PLoS One. 2016 Apr 19;11(4):e0153441. doi: 10.1371/journal.pone.0153441. eCollection 2016.

Reference Type: DERIVED

PMID: 27093291 (View on PubMed)

Other Identifiers

2013-001120-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EC 2013/088

Identifier Type: -

Identifier Source: org_study_id