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

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
Queen's Medical Center
Study ID
NCT05753813
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Bacterial Vaginosis
  • Vulvovaginal Candidiasis

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 54 Years
Healthy Volunteers
Accepted

Interventions

  • Phexxi — DRUG
    intravaginal gel twice weekly for 4 weeks.

Study Details

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.

Key Dates

Start date
Dec 15, 2023
Status verified
Feb 2026
Primary completion
Oct 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Queens Medical Center, 1004 Clinic POB1HonoluluHawaii96813
Olivia H Manayan, MD, MPH
8083487859
Olivia H Manayan, MD MPH (PRINCIPAL_INVESTIGATOR)

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Queens Medical Center, 1004 Clinic POB1· Honolulu, HI

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