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NCT Number: NCT04128488

Effects of Gender-Affirming Hormone Therapy Among Transgender Women

In this study, investigators plan to evaluate the cardiometabolic effects of initiating gender-affirming hormone therapy among transgender women with and without HIV. As part of this study, participants will undergo cardiovascular and metabolic phenotyping within 3 months of starting and after 12 months of gender-affirming hormone therapy. Cardiovascular phenotyping will include cardiac MRI/MRS imaging to evaluate cardiac function and structure. Metabolic phenotyping will include oral glucose tolerance testing, abdominal MR imaging to evaluate visceral adiposity, and whole body, lumbar, and hip DEXA imaging to evaluate fat and lean body mass as well as bone mineral density, respectively. Traditional markers of CVD risk as well as immune, hormonal, and coagulation parameters will also be assessed longitudinally.

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Key information

Conditions

Transgender Women Acquired Immunodeficiency Syndrome Blood-Borne Infections Cardiovascular Diseases Coagulopathy Communicable Diseases Genital Diseases HIV Infections HIV/AIDS Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Vascular Diseases Virus Diseases

Age range

16 year–99 year

Sex eligibility

Male

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • transgender women or non-binary individual
  • age ≥16
  • For women with HIV only: on ART therapy for ≥3 months
  • initiation of testosterone suppression with spironolactone or leuprolide and estrogen therapy with oral 17-β estradiol, transdermal 17β estradiol, sublingual estradiol, intramuscular estradiol, or subcutaneous estradiol by medical provider

Exclusion criteria

  • For women with HIV only: CD4 count<50
  • history of CAD, ACS, ASCVD risk score ≥ 7.5%, LDL-C ≥ 190, or angina (e.g. current indication for statin use)
  • history of heart failure
  • history of diabetes
  • eGFR < 30 ml/min/1.73m2
  • standard contraindication to MRI, including history of severe allergy to gadolinium or Dotarem
  • prior orchiectomy
  • gender-affirming hormone therapy for greater than 5 months directly prior to enrollment
  • current or past anti-platelet therapy or anti-coagulant therapy within the last 6 months •current or past statin therapy within the last 6 months
  • concurrent enrollment in conflicting research study

Treatment and study plan

Abdominal MR Imaging

Other

Imaging to evaluate visceral adipose tissue and hepatic lipid content

Cardiac MRI/MRS

Other

Imaging to evaluate cardiac function and structure

Oral Glucose Tolerance Testing

Other

Blood testing to evaluate changes in glucose and insulin in response to oral glucose load

Whole Body, Lumbar Spine, and Hip DEXA Imaging

Other

Imaging to evaluate fat and lean body mass as well as bone mineral density

Primary outcomes

  1. Change in Visceral Adipose Tissue

    Time frame: Baseline and 12 months

Secondary outcomes

  1. Change in Intramyocardial Triglyceride Content on Cardiac MRS

    Time frame: Baseline and 12 months

  2. Change in Diastolic Function on Cardiac MRI

    Time frame: Baseline and 12 months

  3. Change in Myocardial Fibrosis on Cardiac MRI

    Time frame: Baseline and 12 months

  4. Change in Glucose and Insulin Parameters on Oral Glucose Tolerance Testing

    Time frame: Baseline and 12 months

  5. Change in Bone Density

    Time frame: Baseline and 12 months

  6. Change in Hormonal Parameters

    Time frame: Baseline and 12 months

  7. Change in Coagulation Parameters

    Time frame: Baseline and 12 months

  8. Change in hepatic lipid content

    Time frame: Baseline and 12 months

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Heart Association
  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)
  • Robert Wood Johnson Foundation

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 16, 2019
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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