RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-03-01
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06247267

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female DoD health care beneficiaries
  2. * Ages 18-65
  3. * Diagnosed with primary hypogonadism or transgender treatment for at least 6 months
  4. * Under care for gender identity dysphoria
  5. * On stable dose of sex steroid hormonal therapy for at least 6 months prior to enrolling
  6. * Must be living in the Washington, D.C. area for at least 12 months following enrollment
  1. * Pregnancy, plan for pregnancy in the next 12 months
  2. * Cardiac disease, especially coronary artery disease
  3. * Malabsorption disorder
  4. * Gastrointestinal surgeries
  5. * Significant renal or liver dysfunction
  6. * Seizure disorders
  7. * recent orders to move out of the geographic area
  8. * Age less than 18 years old or older than 65 years old
  9. * Scheduled for deployment

Contacts and Locations

Study Contact

CAPT Than D Hoang, D.O., MC, USN
CONTACT
301-295-5165
thanh.d.hoang.mil@health.mil
Iris E Robbins, BA
CONTACT
301-319-4599
iris.e.robbins1.civ@health.mil

Principal Investigator

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

Study Locations (Sites)

Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
United States

Collaborators and Investigators

Sponsor: Walter Reed National Military Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-03-01
Study Completion Date2025-01

Study Record Updates

Study Start Date2019-03-01
Study Completion Date2025-01

Terms related to this study

Keywords Provided by Researchers

  • Transgender
  • Gender dysphoria
  • Hypogonadism

Additional Relevant MeSH Terms

  • Hypogonadism
  • Gender Identity Dysphoria