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Observational Study on Sex Steroid Replacement Therapy for Hypogonadism and Transgender Individuals

This study is looking at how sex steroid hormone replacement therapy affects body composition and bone density in people with hypogonadism (a condition where the body doesn't produce enough sex hormones) and transgender individuals. Participants will receive either Fortesta (testosterone) or Estradiol (estrogen) and/or spironolactone, depending on their needs, for 12 months. Researchers want to see how these treatments impact your body composition and bone mineral density. You might be eligible if you are 18-65 years old, a DoD health care beneficiary, have been diagnosed with primary hypogonadism or are receiving transgender treatment for at least 6 months, are under care for gender identity dysphoria, are on a stable dose of sex steroid hormonal therapy for at least 6 months, and live in the Washington, D.C. area. The study aims to enroll 75 participants.

Study design
This is an observational study, meaning researchers will observe participants who are already receiving treatment. It plans to include 75 participants.
What's involved
Participants will receive Fortesta or Estradiol and/or spironolactone treatment for 12 months.
Compensation
Not stated in the trial record.
Follow-up
The primary effects on body composition and bone mineral density will be measured at 12 months.

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NCT06247267

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

Recruiting
Not specifiedAges 18–65Observational
Walter Reed National Military Medical Center
~75 participants
Updated 2025-07-29 on ClinicalTrials.gov
What's tested:FortestaEstradiol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effects of sex steroid hormone replacement therapy on body composition
Measured over 12 months
+1 more outcome measured

Conditions

Hypogonadism
Gender Identity Dysphoria

Explore related trials

Gender DysphoriaHypogonadism

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Thanh D Hoang, MD · PRINCIPAL_INVESTIGATOR · Walter Reed National Military Medical Center

Who to contact

CAPT Than D Hoang, D.O., MC, USN
[email protected]
301-295-5165
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Effects of sex steroid hormone replacement therapy on body composition12 months

    Subjects will undergo Dual energy X-ray Absorptiometry conducted by the research coordinator assessing bone density, body composition, and risk of fractures.

  • Effects of sex steroid hormone replacement therapy in treating hypogonadism and in transgender patients using Dual energy X-ray Absorptiometry assessing body composition and Bone Mineral Density12 months

    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.