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

Recruiting now · Early Phase 1

Conditions studied: Bacterial Vaginosis, Vulvovaginal Candidiasis

In brief

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.

Key facts

Study ID

NCT05753813

Run by

Queen's Medical Center

People needed

22

Starts

2023-12-15

Expected to finish

2026-12-30

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older, up to 54. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Queens Medical Center, 1004 Clinic POB1 — Honolulu, Hawaii, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.