Effects of Gender-Affirming Hormone Therapy Among Transgender Women
NCT ID: NCT04128488
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
33 participants
OBSERVATIONAL
2019-11-01
2024-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Transgender women and non-binary individuals without HIV
Abdominal MR Imaging
Imaging to evaluate visceral adipose tissue and hepatic lipid content
Cardiac MRI/MRS
Imaging to evaluate cardiac function and structure
Oral Glucose Tolerance Testing
Blood testing to evaluate changes in glucose and insulin in response to oral glucose load
Whole Body, Lumbar Spine, and Hip DEXA Imaging
Imaging to evaluate fat and lean body mass as well as bone mineral density
Transgender women and non-binary individuals with HIV
Abdominal MR Imaging
Imaging to evaluate visceral adipose tissue and hepatic lipid content
Cardiac MRI/MRS
Imaging to evaluate cardiac function and structure
Oral Glucose Tolerance Testing
Blood testing to evaluate changes in glucose and insulin in response to oral glucose load
Whole Body, Lumbar Spine, and Hip DEXA Imaging
Imaging to evaluate fat and lean body mass as well as bone mineral density
Interventions
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Abdominal MR Imaging
Imaging to evaluate visceral adipose tissue and hepatic lipid content
Cardiac MRI/MRS
Imaging to evaluate cardiac function and structure
Oral Glucose Tolerance Testing
Blood testing to evaluate changes in glucose and insulin in response to oral glucose load
Whole Body, Lumbar Spine, and Hip DEXA Imaging
Imaging to evaluate fat and lean body mass as well as bone mineral density
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
99 Years
MALE
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Institutes of Health (NIH)
NIH
American Heart Association
OTHER
Robert Wood Johnson Foundation
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Mabel Toribio
Assistant Professor
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2019P001962
Identifier Type: -
Identifier Source: org_study_id
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