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Recruiting EARLY_Phase 1 NCT05753813

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

Trial Parameters

Condition Bacterial Vaginosis
Sponsor Queen's Medical Center
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 22
Sex FEMALE
Min Age 18 Years
Max Age 54 Years
Start Date 2023-12-15
Completion 2026-10-30
Interventions
Phexxi

Brief 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.

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

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