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Recruiting
NCT05753813
Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome
Conditions: Bacterial Vaginosis, Vulvovaginal Candidiasis
Sex: Female
Ages: 18 Years – 54 Years
Healthy volunteers: 1
Phase: EARLY_PHASE1
Enrollment: 22
Sponsor: Queen's Medical Center
Location: United States
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 18-54FemalePre-menopausalCan speak and read in EnglishDisplays capacity for informed consentHas 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 treatmentExclusion Criteria:Pregnant or trying to become pregnantPost-menopausalUsing NuvaRing deviceA past medical history of kidney disease, recurrent UTI, and/or urinary tract abnormalitiesCurrent UTIUsing Phexxi as a contraceptive during the collection period of the study
Source: ClinicalTrials.gov (NCT05753813). StuddyBuddy aggregates publicly available trial information.