Flourish Vaginal Care System to Establish Neovaginal Microbiome

Vaginal Biome Science

Status: Invitation-only

Conditions: Neovaginal Microbiome

Treatments: Device: Flourish Vaginal Care system

Study type: Interventional

Funder types: Other

Identifiers

NCT05372770

NV0122

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Group 1: Transgender women using Flourish

Experimental group

Description:

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.

Treatment:

Device: Flourish Vaginal Care system

Group 2: Transgender women not using Flourish

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: Flourish Vaginal Care system