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

NCT05753813 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-02-20

No results posted yet for this study

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

Interventions

DRUG

Phexxi

intravaginal gel twice weekly for 4 weeks.

Sponsors & Collaborators

  • University of Hawaii Foundation

    collaborator UNKNOWN

  • Queen's Medical Center

    lead OTHER

Principal Investigators

  • Olivia Manayan, MD, MPH · University of Hawaii

  • Bliss Kaneshiro, MD, MPH · Queen's Medical Center

  • Corrie Miller, DO · University of Hawaii

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
54 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2026-10-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05753813 on ClinicalTrials.gov