The Effect of Sex Steroid Replacement Therapy in the Hypogonadism and Transgender Active-Duty Population

Launched by WALTER REED NATIONAL MILITARY MEDICAL CENTER · Jan 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of hormone replacement therapy, specifically testosterone and estrogen, on individuals diagnosed with hypogonadism (a condition where the body doesn't produce enough sex hormones) and those undergoing treatment for gender identity dysphoria. The goal is to understand how these therapies can improve bone density, cognitive function, and overall quality of life in participants over a period of one year. The study will involve three groups: individuals with untreated hypogonadism, transgender men who are transitioning from female to male, and transgender women transitioning from male to female.

To be eligible for this trial, participants must be between 18 and 65 years old, diagnosed with either primary hypogonadism or have been receiving hormone therapy for at least six months due to gender identity dysphoria. They should also be stable on their hormone therapy for six months before joining the study and must live in the Washington, D.C. area. Participants will be monitored at the start of the study and again at six and twelve months to assess the effects of their treatments. It's important to note that individuals with certain health conditions, such as heart disease or significant liver issues, will not be eligible to participate. This study aims to provide valuable insights into how hormone replacement can benefit both hypogonadal and transgender individuals.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male and female DoD health care beneficiaries
• • Ages 18-65
• • Diagnosed with primary hypogonadism or transgender treatment for at least 6 months
• • Under care for gender identity dysphoria
• • On stable dose of sex steroid hormonal therapy for at least 6 months prior to enrolling
• • Must be living in the Washington, D.C. area for at least 12 months following enrollment
• Exclusion Criteria:
• • Pregnancy, plan for pregnancy in the next 12 months
• • Cardiac disease, especially coronary artery disease
• • Malabsorption disorder
• • Gastrointestinal surgeries
• • Significant renal or liver dysfunction
• • Seizure disorders
• • recent orders to move out of the geographic area
• • Age less than 18 years old or older than 65 years old
• • Scheduled for deployment