Flourish Vaginal Care System to Establish Neovaginal Microbiome
NCT05372770 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2025-07-01
Summary
This study examines whether use of a commercially-available vaginal wellness system is able to establish a microbiome in transgender women.
Conditions
- Neovaginal Microbiome
Interventions
- DEVICE
-
Flourish Vaginal Care system
Flourish includes Restore® vaginal moisturizing gel, a Class II medical device cleared by the FDA, in addition to two other kit components
Sponsors & Collaborators
-
Vaginal Biome Science
lead OTHER
Principal Investigators
-
Christine McGinn, DO · Papillon Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-01-24
- Primary Completion
- 2024-07-01
- Completion
- 2024-12-12
- FDA Device
- Yes
Countries
- United States
Study Locations
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