Flourish Vaginal Care System to Establish Neovaginal Microbiome

NCT05372770 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-07-01

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05372770 on ClinicalTrials.gov