Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-54
SponsorQueen's Medical Center
About this trial
This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in the way of preventing recurrent episodes of BV and candida infections.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-54
Female
Pre-menopausal
Can speak and read in English
Disqualifiers
Pregnant or trying to become pregnant
Post-menopausal
Using NuvaRing device
A past medical history of kidney disease, recurrent UTI, and/or urinary tract abnormalities
Trial design
Design model
Single group
Treatments tested in this trial
Phexxi
Drugintravaginal gel twice weekly for 4 weeks.
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: Study groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To assess participant's baseline vaginal microbiome makeup
NextGen analysis pre-intervention
Time frame
Within one week of recruitment, unless menstruating. If this is the case, the participant will be asked to wait 10 days from the cessation of menses in order to allow restoration of baseline vaginal microbiome2
To assess if the use of Phexxi causes changes in the vaginal microbiome from baseline after thirty days of use
NextGen analysis immediately post-intervention
Time frame
30 days after baseline vaginal swab collection3
To assess if the use of Phexxi causes changes in the vaginal microbiome
NextGen analysis 30 days post-completion of intervention
Time frame
60 days after baseline vaginal swab collection4
To assess participant's baseline vulvovaginitis symptoms
Survey to be completed pre-intervention
Time frame
On day of recruitment to the studySecondary outcomes
1
To assess patient satisfaction/acceptability of this intervention as a therapeutic/prophylactic agent for recurrent vulvovaginitis
Survey at 2 time points: immediately post-intervention, and 30 days post-completion of intervention. This survey is a validated tool to assess for the acceptability, appropriateness, and feasability of an intervention (Acceptability of Intervention Measure, or AIM, Intervention Appropriateness measure, or IAM, and Feasibility of Intervention Measure, or FIM). It lists a number of statements to assess the above measures and asks the participant to circle the ones which apply to them.
Time frame
30 and 60 days after baseline swab collectionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Queen's Medical Center
Lead sponsor
University of Hawaii Foundation
Collaborator
Source ClinicalTrials.gov