Flourish Vaginal Care System to Establish Neovaginal Microbiome

Not Applicable

• Conditions: Neovaginal Microbiome
• Interventions: Device: Flourish Vaginal Care system

• Registration Number: NCT05372770
• Lead Sponsor: Vaginal Biome Science

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 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 Timeline

• Study Start: 2022-01-24
• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-13
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-18
• Primary Completion: 2024-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3: Cisgender women	Flourish Vaginal Care system	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.
Group 1: Transgender women using Flourish	Flourish Vaginal Care system	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.

Primary Outcome Measures

Name	Time	Method
Vaginal microbiome	Collections at time 0, 6 weeks, and 6 months	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.
Vaginal pH	Collections at time 0, 6 weeks, and 6 months	Observation of changes in vaginal pH over six months by pH strip

Secondary Outcome Measures

Name	Time	Method
VSQ	Collections at time 0, 6 weeks, and 6 months	Responses to the Vulvovaginal Symptoms Questionnaire

Trial Locations

Locations (1)

Papillon Wellness Center; 🇺🇸 New Hope, Pennsylvania, United States