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Completed

NCT Number: NCT02314429

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

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.

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Department of Obstetrics & Gynaecology, Ghent University Hospital P4

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal ring releasing lactic acid (racemic mixture)

Device

Primary outcomes

  1. Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy

    Time frame: 1 hour after insertion

  2. Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy

    Time frame: 2 hours after insertion

  3. Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy

    Time frame: 4 hours after insertion

  4. Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy

    Time frame: 8 hours after insertion

  5. Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy

    Time frame: 24 hours after insertion

  6. Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy

    Time frame: 7 days after insertion

Secondary outcomes

  1. Assessment of vaginal pH

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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Acronym: LACRING01

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 11, 2014
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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