Actively Recruiting
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
8 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
Researchers are studying how the contraceptive gel Phexxi might change the vaginal microbiome, focusing on whether it increases helpful lactic acid-producing bacteria. The study aims to see if this change could help prevent recurring bacterial vaginosis (BV) and vaginal yeast infections. This early-phase, single-center trial uses a before-and-after design to measure changes in vaginal bacteria and symptoms over time. Participants will use Phexxi, an intravaginal gel, twice weekly for four weeks. They will receive 8 pre-filled vaginal gel applicators with instructions for use. The study involves three self-collected vaginal swab samples: one before starting the gel, one after 30 days of use, and a final one 30 days after completing the treatment. Participants will also keep a diary of symptoms and events like intercourse or menstruation during the treatment period. Participants will self-collect vaginal swabs at home and send them to the research lab for freezing and DNA sequencing to analyze bacterial changes. They will complete surveys about symptoms and satisfaction with the gel at each collection point. Researchers will monitor changes in vaginal bacteria and symptoms of vulvovaginitis. The entire participation lasts about 60 days, including treatment and follow-up. The study is led by Queen's Medical Center and aims to understand Phexxi's effects on vaginal health.
CONDITIONS
Brief Title
Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 54 years
- Female
- Pre-menopausal
- Can speak and read English
- Able to provide informed consent
- Experienced 2 or more episodes of symptomatic bacterial vaginosis or candida infection in the past year requiring treatment
You will not qualify if you...
- Pregnant or trying to become pregnant
- Post-menopausal
- Currently using NuvaRing contraceptive device
- History of kidney disease, recurrent urinary tract infections, or urinary tract abnormalities
- Current urinary tract infection
- Using Phexxi as contraceptive during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 30 days
Participants use the intravaginal lactic acid gel Phexxi twice weekly for 4 weeks while self-collecting vaginal swabs and completing symptom and acceptability surveys.
3 self-collection time points at home (baseline, end of treatment, and 30 days post-treatment)
Duration - 30 days after treatment completion
Participants continue to self-collect vaginal swabs and complete surveys 30 days after completing the intervention to assess long-term effects.
1 self-collection time point at home
Trial Site Locations
Total: 1 location
1
Queens Medical Center, 1004 Clinic POB1
Honolulu, Hawaii, United States, 96813
Actively Recruiting
Research Team
O
Olivia H Manayan, MD, MPH
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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