Actively Recruiting

Early Phase 1
Age: 18Years - 54Years
FEMALE
Healthy Volunteers
NCT05753813

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

Led by Queen's Medical Center · Updated on 2026-02-20

22

Participants Needed

1

Research Sites

158 weeks

Total Duration

On this page

Sponsors

Q

Queen's Medical Center

Lead Sponsor

U

University of Hawaii Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 54Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Queens Medical Center, 1004 Clinic POB1

Honolulu, Hawaii, United States, 96813

Actively Recruiting

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Research Team

O

Olivia H Manayan, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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