ClinConnect ClinConnect Logo
Search / Trial NCT05753813

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

Launched by QUEEN'S MEDICAL CENTER · Feb 22, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how an intravaginal lactic acid gel, specifically looking at the contraceptive method Phexxi, may change the balance of bacteria in the vagina. Researchers believe that using Phexxi regularly might help increase the number of good bacteria that produce lactic acid, which could help prevent recurring infections like bacterial vaginosis (BV) and yeast infections.

To be eligible for this study, participants need to be women aged 18 to 54 who are pre-menopausal and can read and speak English. They should have had at least two episodes of BV or yeast infections in the past year that required treatment. Unfortunately, women who are pregnant, post-menopausal, or currently have a urinary tract infection (UTI) cannot participate. Those who join can expect to use the gel and share their experiences, contributing valuable information that may help improve treatment for these common conditions in the future.

Gender

FEMALE

Eligibility criteria

  • 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

About Queen's Medical Center

Queen's Medical Center, located in Honolulu, Hawaii, is a leading academic medical institution renowned for its commitment to innovative healthcare and clinical research. As a prominent clinical trial sponsor, Queen's Medical Center is dedicated to advancing medical knowledge and improving patient outcomes through rigorous research protocols and collaboration with various stakeholders in the medical community. The center focuses on a wide range of therapeutic areas, ensuring that its clinical trials adhere to the highest ethical standards and regulatory guidelines. With a patient-centered approach, Queen's Medical Center strives to contribute significantly to the development of new therapies and healthcare solutions that enhance the well-being of the diverse populations it serves.

Locations

Honolulu, Hawaii, United States

Patients applied

0 patients applied

Trial Officials

Olivia Manayan, MD, MPH

Principal Investigator

University of Hawaii

Bliss Kaneshiro, MD, MPH

Principal Investigator

Queen's Medical Center

Corrie Miller, DO

Principal Investigator

University of Hawaii

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials