Effects of Gender-Affirming Hormone Therapy Among Transgender Women

Completed

• Conditions: Cardiovascular Diseases; Transgender Women; Coagulopathy; HIV/AIDS; Metabolic Disease

• Registration Number: NCT04128488
• Lead Sponsor: Massachusetts General Hospital

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, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Study Start: 2019-11-01
• Primary Completion: 2024-03-28
• Study Completion: 2024-03-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 33

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Visceral Adipose Tissue	Baseline and 12 months

Secondary Outcome Measures

Name	Time	Method
Change in Intramyocardial Triglyceride Content on Cardiac MRS	Baseline and 12 months
Change in Myocardial Fibrosis on Cardiac MRI	Baseline and 12 months
Change in Bone Density	Baseline and 12 months
Change in Coagulation Parameters	Baseline and 12 months
Change in Diastolic Function on Cardiac MRI	Baseline and 12 months
Change in Glucose and Insulin Parameters on Oral Glucose Tolerance Testing	Baseline and 12 months
Change in Hormonal Parameters	Baseline and 12 months
Change in hepatic lipid content	Baseline and 12 months

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States