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

NCT02314429 | Completed Phase 1

• 2 other identifiers: EC 2013/0882013-001120-19
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Assessment of vaginal pH

  each 30 minutes for 4 hours after insertion, and then each 60 minutes for the next 4 hours

Study Arms (1)

Vaginal Ring

EXPERIMENTAL

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)

Interventions

Vaginal ring releasing lactic acid (racemic mixture) DEVICE

Vaginal Ring

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good general physical and mental health
• Presence of normal (lactobacilli-dominated) vaginal microbiota
• Prepared to take oral contraception during the study

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Department of Obstetrics & Gynaecology, Ghent University Hospital P4

Ghent, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 27093291 DERIVED

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Hans Verstraelen, Prof. dr.

  University & University Hospital Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 11, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: September 1, 2015
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

BE (1)