CompletedNot Applicable

Flourish Vaginal Care System to Establish Neovaginal Microbiome

United States56 participantsStarted 2022-01-24

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. 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.

Vaginal microbiome

Timeframe: Collections at time 0, 6 weeks, and 6 months

Vaginal pH

Timeframe: Collections at time 0, 6 weeks, and 6 months

NCT IDNCT05372770

SponsorVaginal Biome Science

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-01