Status:
COMPLETED
Effects of Gender-Affirming Hormone Therapy Among Transgender Women
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Conditions:
Transgender Women
HIV/AIDS
Eligibility:
MALE
16-99 years
Brief Summary
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, participan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 28 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04128488
Start Date
November 1 2019
End Date
March 28 2024
Last Update
May 18 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114