NCT04128488Completed
Effects of Gender-Affirming Hormone Therapy Among Transgender Women
Source: ClinicalTrials.gov · Last updated 18 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 33 (actual)
- First submitted
- 14 Oct 2019
- Start date
- 1 Nov 2019
- Primary completion date
- 28 Mar 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- HIV
- NCT number
- NCT04128488
What you commit to
- Study type: Observational
- Participants enrolled: 33
- From 1 Nov 2019 to the primary completion date, 28 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- prior orchiectomy
- gender-affirming hormone therapy for greater than 5 months directly prior to enrollment
- concurrent enrollment in conflicting research study
Other illness
- 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
- standard contraindication to MRI, including history of severe allergy to gadolinium or Dotarem
Lab values
- For women with HIV only: CD4 count\<50
- eGFR \< 30 ml/min/1.73m2
- 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
Who the study is looking for
- 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
Age in the registry: 16 years to 99 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.