Status:
COMPLETED
Flourish Vaginal Care System to Establish Neovaginal Microbiome
Lead Sponsor:
Vaginal Biome Science
Conditions:
Neovaginal Microbiome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study examines whether use of a commercially-available vaginal wellness system is able to establish a microbiome in transgender women.
Detailed Description
Very little is known about the neovaginal microbiome, but it has been described as being a polymicrobial state similar to bacterial vaginosis (BV) in cis women. The Flourish Vaginal Care System is a c...
Eligibility Criteria
Inclusion
- Transgender women over age 18 who are preparing to undergo gender-confirmation surgery.
- Healthy cisgender women ages 18-52
Exclusion
- Immunosuppressed
- Known allergies or sensitivities to aloe vera or to other components of Restore®, Balance, or BiopHresh®
- Known (neo)vaginal infection that is not yeast or BV at start of protocol
- Inability to tolerate Restore gel by day 13 after surgery.
Key Trial Info
Start Date :
January 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05372770
Start Date
January 24 2022
End Date
December 12 2024
Last Update
July 1 2025
Active Locations (1)
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1
Papillon Wellness Center
New Hope, Pennsylvania, United States, 18938