Recruiting

Early Phase 1

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

Sponsor:

Queen's Medical Center

Code:

NCT05753813

Conditions

Bacterial Vaginosis

Vulvovaginal Candidiasis

Eligibility Criteria

Sex: Female

Age: 18 - 54

Healthy Volunteers: Accepted

Interventions

Phexxi

Study Details

Brief 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.

Conditions

Bacterial Vaginosis

Vulvovaginal Candidiasis

Study ID

NCT05753813

Start date

Dec 15, 2023

Status verified date

Feb, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 54

Healthy Volunteers: Accepted

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

Study Design

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Study group

This is a single-arm study. all participants are assigned to this arm. all study participants will receive Phexxi, the study drug. 8 pre-filled vaginal inserters with vaginal gel, Phexxi, will be provided to each of the participants with verbal and written instructions for application. Patients will be instructed to use Phexxi twice per week, on the same days every week.

Interventions

Phexxi

intravaginal gel twice weekly for 4 weeks.

Primary outcome measure

To assess participant's baseline vaginal microbiome makeup [ 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 microbiome ]
To assess if the use of Phexxi causes changes in the vaginal microbiome from baseline after thirty days of use [ Time Frame: 30 days after baseline vaginal swab collection ]
To assess if the use of Phexxi causes changes in the vaginal microbiome [ Time Frame: 60 days after baseline vaginal swab collection ]
To assess participant's baseline vulvovaginitis symptoms [ Time Frame: On day of recruitment to the study ]
To assess if the use of Phexxi decreases vulvovaginitis symptoms in study participants [ Time Frame: 30 days after baseline vaginal swab collection ]
To assess if the use of Phexxi decreases vulvovaginitis symptoms in study participants [ Time Frame: 60 days after baseline vaginal swab collection ]

Central Contacts and Locations

Central contacts

Olivia H Manayan, MD, MPH

808-348-7859 omanayan@hawaii.edu

Locations

Queens Medical Center, 1004 Clinic POB1

Recruiting

Honolulu, Hawaii, United States, 96813

Contacts

Olivia H Manayan, MD, MPH

8083487859

Principal Investigator:

Olivia H Manayan, MD MPH

More Information

Sponsor

Queen's Medical Center

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Queen's Medical Center on 2026-02-20.