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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Honolulu, Hawaii, United States
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
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