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

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Queen's Medical Center
• Collaborator: University of Hawaii Foundation

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