RecruitingEarly Phase 1NCT05753813

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

Sponsor

Queen's Medical Center

Enrollment

22 participants

Start Date

Dec 15, 2023

Study Type

INTERVENTIONAL

Conditions

Vulvovaginal candidiasis Bacterial vaginosis

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

Sex: FEMALEMin Age: 18 YearsMax Age: 54 Years

Inclusion Criteria6

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 Criteria6

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