Clinical Trial

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

Recruiting Early Phase 1
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-02-22; most recent amendment 2026-02-18.
Trial Details
NCT Number NCT05753813
Lead Sponsor Queen's Medical Center
Collaborators: University of Hawaii Foundation
Conditions Bacterial Vaginosis, Vulvovaginal Candidiasis
Enrollment 22 participants
Start Date 2023-12-15
Primary Completion 2026-10-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-20