Recruiting

Hormone Replacement Therapy

Sponsor:

Walter Reed National Military Medical Center

Code:

NCT06247267

Conditions

Hypogonadism

Gender Identity Dysphoria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Fortesta

Estradiol

Fortesta

Study Details

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.

Conditions

Hypogonadism

Gender Identity Dysphoria

Study ID

NCT06247267

Start date

Mar 9, 2021

Status verified date

Jul, 2025

Completion date

Aug, 2025

Anticipated

Primary completion date

Aug, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary/Secondary Untreated Hypogonadism

Subjects in group 1 will take clinically indicated testosterone replacement therapy (Fortesta-injection, gel and transdermal) for 12 months with titration for a serum total T level between 300-600 ng/dL.

Male-to-Female (MTF)

Subjects in group 2 will take clinically indicated estrogen therapy (Estradiol-orally and transdermal and/or spironolactone-orally) for 12 months for hormonal transition period.

Female-to-Male (FTM)

Subjects in group 3 will take clinically indicated testoserone replacement therapy (Fortesta-injection, gel and transdermal) for 12 months for hormonal transition period.

Interventions

Fortesta

Primary/secondary untreated hypogonadism patients receive Fortesta injection, gel and transdermal treatment for 12 months with titration for a serum total T level between 300-600ng/dL.

Estradiol

Male-to-female (MTF) receive Estradiol orally and transdermal and/or spironolactone-orally) treatment for 12 months for hormonal transition period.

Fortesta

Female-to-male (FTM) receive Fortesta injection, gel and transdermal treatment for 12 months for hormonal transition period.

Primary outcome measure

  • Effects of sex steroid hormone replacement therapy on body composition [ Time Frame: 12 months ]
  • 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 Density [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889-5600

Contacts

Principal Investigator:

Thanh D Hoang, DO

More Information

Sponsor

Walter Reed National Military Medical Center

Last update posted

Jul 29, 2025

Last verified

Jul, 2025

Keywords

  • Transgender
  • Gender dysphoria
  • Hypogonadism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Walter Reed National Military Medical Center on 2025-07-29.