Flourish Vaginal Care System to Establish Neovaginal Microbiome

Pilot Study to Observe Effects of Using Flourish Vaginal Care System to Establish Neovaginal Microbiome After Gender-Confirmation Surgery

This study examines whether use of a commercially-available vaginal wellness system is able to establish a microbiome in transgender women.

Study Overview

• Status: Completed
• Conditions: Neovaginal Microbiome
• Intervention / Treatment: Device: Flourish Vaginal Care system

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 commercially-available over-the-counter vaginal wellness kit that helps relieve symptoms of BV. This study is intended to determine whether that kit could also help transgender women who have recently undergone gender-confirming surgery to establish a neovaginal microbiome that is dominated by lactobacilli, as observed in healthy cis women. This could increase health and subjective satisfaction of the neovagina. This study examines the (neo)vaginal microbiome in transgender women with and without using Flourish, as well as a group of healthy cisgender women.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • New Hope, Pennsylvania, United States, 18938
      • Papillon Wellness Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Transgender women over age 18 who are preparing to undergo gender-confirmation surgery.
2. Healthy cisgender women ages 18-52

Exclusion Criteria:

1. Immunosuppressed
2. Known allergies or sensitivities to aloe vera or to other components of Restore®, Balance, or BiopHresh®
3. Known (neo)vaginal infection that is not yeast or BV at start of protocol
4. Inability to tolerate Restore gel by day 13 after surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: Transgender women using Flourish; After gender-confirming surgery, this group will use the Flourish Vaginal Care System for six months, ramping up usage with healing. They will use "Balance" external wash beginning day 6 after surgery; "Restore®" vaginal moisturizing gel on dilators beginning day 6 after surgery; Restore every other day at bedtime with "BiopHresh" homeopathic/probiotic suppository every 3rd day at bedtime beginning week 6 after surgery through end of study at 6 months.	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
No Intervention: Group 2: Transgender women not using Flourish; After gender-confirming surgery, this group will use only KY jelly on dilators beginning day 6 after surgery according to routine care; they will use any standard hygiene product (soap, body wash, etc) of their choice except products used by Group 1 through the end of the study at 6 months.
Other: Group 3: Cisgender women; This group will use the Flourish Vaginal Care system for 6 months: Balance external wash daily; Restore intravaginal gel every other day at bedtime; BiopHresh homeopathic/probiotic suppository every 3rd day at bedtime through the end of study.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal microbiome	Observation of changes in the composition of the vaginal fluid microbiome over six months using commercially available next-generation sequencing kit (16s rRNA). Biomes will be categorized to "community state type" (Ravel 2011), and genus- or species-level relative abundance will be compared.	Collections at time 0, 6 weeks, and 6 months
Vaginal pH	Observation of changes in vaginal pH over six months by pH strip	Collections at time 0, 6 weeks, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VSQ	Responses to the Vulvovaginal Symptoms Questionnaire	Collections at time 0, 6 weeks, and 6 months

Collaborators and Investigators

• Sponsor: Vaginal Biome Science
• Collaborators: Papillon Center
• Investigators: Principal Investigator: Christine McGinn, DO, Papillon Center

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2022
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): December 12, 2024

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 29, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: probiotic; transgender; microbiome; lactobacillus; neovagina
• Other Study ID Numbers: NV0122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No