RecruitingEarly Phase 1

Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome

United States22 participantsStarted 2023-12-15

Plain-language summary

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.

Who can participate

Age range

18 Years – 54 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-54 * Female * Pre-menopausal * Can speak and read in English * Displays capacity for informed consent * Has had 2 or more documented and/or self-reported episodes of symptomatic BV or candida infection in the last year, requiring, over-the-counter or prescription treatment Exclusion Criteria: * 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 * Current UTI * Using Phexxi as a contraceptive during the collection period of the study

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To assess participant's baseline vaginal microbiome makeup

Timeframe: 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 microbiome

To assess if the use of Phexxi causes changes in the vaginal microbiome from baseline after thirty days of use

Timeframe: 30 days after baseline vaginal swab collection

To assess if the use of Phexxi causes changes in the vaginal microbiome

Timeframe: 60 days after baseline vaginal swab collection

To assess participant's baseline vulvovaginitis symptoms

Timeframe: On day of recruitment to the study

To assess if the use of Phexxi decreases vulvovaginitis symptoms in study participants

Timeframe: 30 days after baseline vaginal swab collection

To assess if the use of Phexxi decreases vulvovaginitis symptoms in study participants

Timeframe: 60 days after baseline vaginal swab collection

Trial details

NCT IDNCT05753813

SponsorQueen's Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-10-30

Contact for this trial

Olivia H Manayan, MD, MPH

808-348-7859 omanayan@hawaii.edu

View on ClinicalTrials.gov More Bacterial Vaginosis trials

Plain-language summary

Who can participate

Age range

18 Years – 54 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

To assess participant's baseline vaginal microbiome makeup

To assess if the use of Phexxi causes changes in the vaginal microbiome from baseline after thirty days of use

Timeframe: 30 days after baseline vaginal swab collection

To assess if the use of Phexxi causes changes in the vaginal microbiome

Timeframe: 60 days after baseline vaginal swab collection

To assess participant's baseline vulvovaginitis symptoms

Timeframe: On day of recruitment to the study

To assess if the use of Phexxi decreases vulvovaginitis symptoms in study participants

Timeframe: 30 days after baseline vaginal swab collection

To assess if the use of Phexxi decreases vulvovaginitis symptoms in study participants

Timeframe: 60 days after baseline vaginal swab collection