Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 25, 2023
Date Accepted: Nov 3, 2023
Effectiveness and Safety of Different Estradiol Regimens in Transgender Females (TREAT Study): Protocol for a Randomized Control Trial
ABSTRACT
Background:
Current guidelines for gender affirming hormone therapy for transgender females are mostly based on clinical experience from experts in the field and on treatments used on postmenopausal women. While care is currently provided with the best available evidence, there is a critical gap in knowledge about the safest and most effective regimens for gender affirming hormone therapy in transgender women; this statement is supported by the World Professional Association for Transgender Health on their Standards of Care for the Health of Transgender and Gender Diverse People, version 8.
Objective:
This randomized pilot study evaluated the degree of testosterone suppression achieved at 1, 6 and 12 months in treatment-naive transgender females when placed on sublingual 17-beta estradiol, once or twice daily, or transdermal 17-beta estradiol for gender affirming hormone therapy over the first year of treatment and to assess treatment effect on metabolic and coagulation factors at 6 and 12 months after initiating GAHT.
Methods:
The proposed study is a prospective pilot, open label, randomized clinical trial conducted at an adult transgender clinic in a tertiary medical center. Transgender females 18 to 45 years of age who are being evaluated for initiation of gender affirming hormone therapy with 17-beta estradiol and do not have a history of coagulopathy, history of cigarette smoking, liver disease, dyslipidemia requiring treatment, or use of GnRH agonist were eligible to enroll. Participants where randomized to one of three treatment arms including once daily sublingual 17-beta estradiol, twice daily sublingual 17-beta estradiol, and transdermal 17-beta estradiol. All participants received spironolactone as antiandrogen. The primary outcome was the total testosterone level at 1 and 6 months after GAHT initiation.
Results:
The study was funded in March 2022 and enrollment has concluded. Study ended in July 2023. Currently, results are being analyzed for publication.
Conclusions:
The TREAT study offers a rigorous and reproducible approach to answer important questions regarding the gender affirming hormone therapy in transgender females. Specifically, the most effective 17-beta estradiol regimen to suppress testosterone levels to 50 ng/dL, as currently recommended. Clinical Trial: ClinicalTrials.gov NCT05010707
Citation
Request queued. Please wait while the file is being generated. It may take some time.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.