Flourish Vaginal Care System to Establish Neovaginal Microbiome

NCT05372770 | Completed FDA Device

• 1 other identifier: NV0122
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

neovagina; microbiome; lactobacillus; transgender; probiotic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• VSQ

  Collections at time 0, 6 weeks, and 6 months

Study Arms (3)

Group 1: Transgender women using Flourish

EXPERIMENTAL

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

Group 2: Transgender women not using Flourish

NO INTERVENTION

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.

Group 3: Cisgender women

OTHER

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

Interventions

Flourish Vaginal Care system DEVICE

Flourish includes Restore® vaginal moisturizing gel, a Class II medical device cleared by the FDA, in addition to two other kit components

Group 1: Transgender women using Flourish; Group 3: Cisgender women

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Individuals must be either 1) transgender women who are undergoing gender-confirming surgery; or 2) cisgender women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vaginal Biome Science: lead

Study Sites (1)

Papillon Wellness Center

New Hope, Pennsylvania, 18938, United States

Location

Study Officials

• Christine McGinn, DO

  Papillon Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups of transgender women who have undergone surgery plus a group of healthy cisgender women who have not undergone surgery

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 13, 2022
• Study Start: January 24, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 12, 2024
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)