Flourish Vaginal Care System to Establish Neovaginal Microbiome

• Sponsor: Sexual Health and Wellness Institute (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05372770
• Collaborator: Papillon Center (Other)
• Enrollment: 60
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 34.2
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neovaginal Microbiome	Device: Flourish Vaginal Care system	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two groups of transgender women who have undergone surgery plus a group of healthy cisgender women who have not undergone surgeryTwo groups of transgender women who have undergone surgery plus a group of healthy cisgender women who have not undergone surgery
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Pilot Study to Observe Effects of Using Flourish Vaginal Care System to Establish Neovaginal Microbiome After Gender-Confirmation Surgery
• Actual Study Start Date: Jan 24, 2022
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. VSQ [Collections at time 0, 6 weeks, and 6 months]

   Responses to the Vulvovaginal Symptoms Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Papillon Wellness Center	New Hope	Pennsylvania	United States	18938

Sponsors and Collaborators

• Sexual Health and Wellness Institute
• Papillon Center

Investigators

• Principal Investigator: Christine McGinn, DO, Papillon Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sexual Health and Wellness Institute
• ClinicalTrials.gov Identifier: NCT05372770
• Other Study ID Numbers: NV0122
• First Posted: May 13, 2022
• Last Update Posted: May 13, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Sexual Health and Wellness Institute: neovagina; microbiome; lactobacillus; transgender; probiotic

Study Results

No Results Posted as of May 13, 2022