Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 54
Healthy Volunteers: t
View:
• 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
Locations
United States
Hawaii
Queens Medical Center, 1004 Clinic POB1
RECRUITING
Honolulu
Contact Information
Primary
Olivia H Manayan, MD, MPH
omanayan@hawaii.edu
808-348-7859
Time Frame
Start Date: 2023-12-15
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 22
Treatments
Experimental: Study group
This is a single-arm study. all participants are assigned to this arm. all study participants will receive Phexxi, the study drug. 8 pre-filled vaginal inserters with vaginal gel, Phexxi, will be provided to each of the participants with verbal and written instructions for application. Patients will be instructed to use Phexxi twice per week, on the same days every week.
Related Therapeutic Areas
Sponsors
Collaborators: University of Hawaii Foundation
Leads: Queen's Medical Center