Examining the effects of sex steroid replacement therapy in transgender military personnel with hypogonadism
The Effect on Sex Steroid Replacement Therapy in the Hypogonadism and Transgender Active-Duty Population on Bone Density, Fractures, Memory/Cognitive Function and Qualities of Life
This study tests how hormone therapy affects the health and well-being of active-duty military personnel with low testosterone and gender identity issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Walter Reed National Military Medical Center Federal |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06247267 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of sex steroid replacement therapy on active-duty military personnel diagnosed with hypogonadism and gender identity dysphoria. It focuses on individuals receiving testosterone or estrogen therapy to assess physiological changes and health outcomes associated with these treatments. Participants must be stable on their hormonal therapy for at least six months and will be monitored for various health indicators related to bone density and mental health. The study aims to gather data to better understand the needs of this growing patient population within the military healthcare system.
Who should consider this trial
Good fit: Ideal candidates include male and female Department of Defense healthcare beneficiaries aged 18-65 who have been diagnosed with primary hypogonadism or are undergoing transgender treatment for at least six months.
Not a fit: Patients who are pregnant, have significant cardiac or renal issues, or are scheduled for deployment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of hypogonadism and gender identity dysphoria in military personnel, leading to better health outcomes and quality of life.
How similar studies have performed: While there is limited data on large-scale studies, some smaller studies have indicated potential benefits of sex steroid replacement therapy in similar populations, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bethesda, Maryland
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Thanh D Hoang, MD — Walter Reed National Military Medical Center
- Study coordinator: CAPT Than D Hoang, D.O., MC, USN
- Email: thanh.d.hoang.mil@health.mil
- Phone: 301-295-5165
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.