Vaginosis, BacterialPhase 1LACRING01NCT02314429
Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis
A Phase 1 study testing Vaginal ring releasing lactic acid (racemic mixture) in people with Vaginosis, Bacterial, run by University Ghent at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginosis, Bacterial
- What is being tested?
- Vaginal ring releasing lactic acid (racemic mixture)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good general physical and mental health
- Presence of normal (lactobacilli-dominated) vaginal microbiota
- Prepared to take oral contraception during the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Obstetrics & Gynaecology, Ghent University Hospital P4
Ghent, 9000
About this study
Official title: Phase I 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.
- Conditions
- Vaginosis, Bacterial
- Being tested
- Vaginal ring releasing lactic acid (racemic mixture)
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal ring releasing lactic acid (racemic mixture)Device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Vaginal ring releasing lactic acid (racemic mixture) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Measured: 1 hour after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Measured: 2 hours after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Measured: 4 hours after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Measured: 8 hours after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Measured: 24 hours after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Measured: 7 days after insertion
Secondary outcomes (1)
Assessment of vaginal pH
Measured: each 30 minutes for 4 hours after insertion, and then each 60 minutes for the next 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginosis, BacterialStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hans Verstraelen, Prof. dr., Principal investigator, University & University Hospital Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314429
- Sponsor's protocol ID
- EC 2013/088
- Other IDs
- 2013-001120-19
- Acronym
- LACRING01
- Status last verified
- Mar 2016
- First submitted
- 2 Dec 2014
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27093291
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT02314429
- Acronym / sponsor ID
- LACRING01 / EC 2013/088
- Conditions
- Vaginosis, Bacterial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 11 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal Ring | Experimental | Device: Vaginal ring releasing lactic acid (racemic mixture)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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Good general physical and mental health
- Presence of normal (lactobacilli-dominated) vaginal microbiota
- Prepared to take oral contraception during the study
Key exclusion criteria (7 listed)
- Pregnancy
- Lactation
- Systemic disease
- Menopause
- Recent use of antibiotics (<1 week before entering the study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal ring releasing lactic acid (racemic mixture) | Device | Vaginal Ring |
Primary outcome
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Time frame: 1 hour after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Time frame: 2 hours after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Time frame: 4 hours after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Time frame: 8 hours after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Time frame: 24 hours after insertion
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
Time frame: 7 days after insertion
1 secondary outcome
Assessment of vaginal pH
Time frame: each 30 minutes for 4 hours after insertion, and then each 60 minutes for the next 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Derived from this study: PubMed 27093291Verstraelen 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.
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Verstraelen, Prof. dr. principal investigator
University & University Hospital Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vaginal ring releasing lactic acid (racemic mixture) in people with Vaginosis, Bacterial, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy (time frame: 1 hour after insertion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02314429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2016.