NCT06247267 The Effect of Sex Steroid Replacement Therapy in the Hypogonadism and Transgender Active-Duty Population

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 75 participants in total. It began in 2021-03-09 with a primary completion date of 2025-08.

Brief Summary

It has been known that both estrogen and testosterone are the major sex steroids regulating bone metabolism and other physiological changes in both male and female, respectively. In postmenopausal women, osteoporosis is a major concern secondary to the lack of estrogen. These patients also experience a number of physiological changes that affect their life permanently to include hot flashes, irritability, difficulty concentrating, depression and mental confusion. In hypogonadal men, testosterone deficiency could lead to higher prevalence of depression, osteoporosis, fracture and frailty. Given the new military policy starting to support treatment for gender identity dysphoria military personnel, the number of transgender patients in our Endocrinology clinic has been slowly increasing over the past several months. These patients will require either testosterone replacement therapy or estrogen therapy to achieve their desired sexual characteristics. However, as mentioned above, the lack of estrogen or testosterone in female and male, respectively, could cause several issue in their body composition, cognitive function and quality of life. We designed this prospective case-control study to include patients with hypogonadism and the transgendered populations to learn about the long-term effects of these hormonal replacement therapies on bone density, fractures, memory/cognitive function and quality of life. This is a repetitive measures study taken at baseline, 6-months, and 12-months for three groups consisting of at least 75 subjects. The study will involve 3 arms, i.e. Group 1 primary/secondary untreated hypogonadism, Group 2 male-to female (MTF), and Group 3 female-to-male (FTM) participants that are planning to start hormone replacement therapy as per standard clinical guidelines.

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

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