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

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Oct 30, 2025 to Oct 30, 2026
    • Study completion date: Dec 30, 2025 to Dec 30, 2026
    • Site contact updated
    v3
  2. Primary completion date: Jun 30, 2023 to Oct 30, 2025
    • Start date changed from estimate of Feb 27, 2023 to Dec 15, 2023
    • Study completion date: Jun 30, 2023 to Dec 30, 2025
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05753813
Lead Sponsor Queen's Medical Center
Collaborators: University of Hawaii Foundation
Conditions
(from sponsor)		 Bacterial Vaginosis, Vulvovaginal Candidiasis
Related terms Candidiasis, Vulvovaginal, Vaginosis, Bacterial
Enrollment 22 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov