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

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ClinicalTrials.gov Identifier: NCT02314429
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent ( University Ghent )

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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 : September 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaginal Diseases

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)



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314429


Locations
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Belgium
Department of Obstetrics & Gynaecology, Ghent University Hospital P4
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Hans Verstraelen, Prof. dr. University & University Hospital Ghent

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT02314429     History of Changes
Other Study ID Numbers: EC 2013/088
2013-001120-19 ( EudraCT Number )
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
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Vaginal Diseases
Vaginosis, Bacterial
Genital Diseases, Female
Bacterial Infections
Vaginitis