Skip to main content
OpenTrials
Completed

NCT Number: NCT05372770

Flourish Vaginal Care System to Establish Neovaginal Microbiome

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neovaginal Microbiome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Papillon Wellness Center

New Hope, Pennsylvania, 18938, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Vaginal microbiome

    Time frame: 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

    Time frame: Collections at time 0, 6 weeks, and 6 months

    Observation of changes in vaginal pH over six months by pH strip

Secondary outcomes

  1. VSQ

    Time frame: Collections at time 0, 6 weeks, and 6 months

    Responses to the Vulvovaginal Symptoms Questionnaire

Sponsors and collaborators

Lead sponsor

Vaginal Biome Science

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
May 13, 2022
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.