Transgender WomenNCT04128488
Effects of Gender-Affirming Hormone Therapy Among Transgender Women
An observational study of Transgender Women and HIV/AIDS, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Transgender Women, HIV/AIDS, Cardiovascular Diseases
- What is being tested?
- Abdominal MR Imaging, Cardiac MRI/MRS and Oral Glucose Tolerance Testing
- Type of treatment
- Pill or oral medicine
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 28 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Transgender Women and Non-Binary Individuals
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Being tested
- Abdominal MR Imaging, Cardiac MRI/MRS, Oral Glucose Tolerance Testing, Whole Body, Lumbar Spine, and Hip DEXA Imaging
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Cardiovascular Diseases, Metabolic Diseases, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal MR ImagingOther
Imaging to evaluate visceral adipose tissue and hepatic lipid content
Cardiac MRI/MRSOther
Imaging to evaluate cardiac function and structure
Oral Glucose Tolerance TestingOther
Blood testing to evaluate changes in glucose and insulin in response to oral glucose load
Whole Body, Lumbar Spine, and Hip DEXA ImagingOther
Imaging to evaluate fat and lean body mass as well as bone mineral density
| Study group | Role | What they receive |
|---|---|---|
| Transgender women and non-binary individuals without HIV | Not described Receives: Other: Abdominal MR Imaging; Other: Cardiac MRI/MRS; Other: Oral Glucose Tolerance Testing; Other: Whole Body, Lumbar Spine, and Hip DEXA Imaging | |
| Transgender women and non-binary individuals with HIV | Not described Receives: Other: Abdominal MR Imaging; Other: Cardiac MRI/MRS; Other: Oral Glucose Tolerance Testing; Other: Whole Body, Lumbar Spine, and Hip DEXA Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visceral Adipose Tissue
Measured: Baseline and 12 months
Secondary outcomes (8)
Change in Intramyocardial Triglyceride Content on Cardiac MRS
Measured: Baseline and 12 months
Change in Diastolic Function on Cardiac MRI
Measured: Baseline and 12 months
Change in Myocardial Fibrosis on Cardiac MRI
Measured: Baseline and 12 months
Change in Glucose and Insulin Parameters on Oral Glucose Tolerance Testing
Measured: Baseline and 12 months
Change in Bone Density
Measured: Baseline and 12 months
Change in Hormonal Parameters
Measured: Baseline and 12 months
Change in Coagulation Parameters
Measured: Baseline and 12 months
Change in hepatic lipid content
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start1 Nov 2019
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transgender WomenStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), American Heart Association, Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Mabel Toribio, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128488
- Sponsor's protocol ID
- 2019P001962
- Other IDs
- 1K23HL147799-01
- Status last verified
- May 2025
- First submitted
- 14 Oct 2019
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gender-Affirming Hormone Therapy Among Transgender Women
- ClinicalTrials.gov ID
- NCT04128488
- Acronym / sponsor ID
- 2019P001962
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), American Heart Association, Robert Wood Johnson Foundation
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transgender women and non-binary individuals without HIV | – | Other: Abdominal MR Imaging, Other: Cardiac MRI/MRS, Other: Oral Glucose Tolerance Testing, Other: Whole Body, Lumbar Spine, and Hip DEXA Imaging |
| Transgender women and non-binary individuals with HIV | – | Other: Abdominal MR Imaging, Other: Cardiac MRI/MRS, Other: Oral Glucose Tolerance Testing, Other: Whole Body, Lumbar Spine, and Hip DEXA Imaging |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Transgender Women and Non-Binary Individuals
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal MR ImagingImaging to evaluate visceral adipose tissue and hepatic lipid content | Other | Transgender women and non-binary individuals with HIV, Transgender women and non-binary individuals without HIV |
| Cardiac MRI/MRSImaging to evaluate cardiac function and structure | Other | Transgender women and non-binary individuals with HIV, Transgender women and non-binary individuals without HIV |
| Oral Glucose Tolerance TestingBlood testing to evaluate changes in glucose and insulin in response to oral glucose load | Other | Transgender women and non-binary individuals with HIV, Transgender women and non-binary individuals without HIV |
| Whole Body, Lumbar Spine, and Hip DEXA ImagingImaging to evaluate fat and lean body mass as well as bone mineral density | Other | Transgender women and non-binary individuals with HIV, Transgender women and non-binary individuals without HIV |
Primary outcome
Change in Visceral Adipose Tissue
Time frame: Baseline and 12 months
8 secondary outcomes
Change in Intramyocardial Triglyceride Content on Cardiac MRS
Time frame: Baseline and 12 months
Change in Diastolic Function on Cardiac MRI
Time frame: Baseline and 12 months
Change in Myocardial Fibrosis on Cardiac MRI
Time frame: Baseline and 12 months
Change in Glucose and Insulin Parameters on Oral Glucose Tolerance Testing
Time frame: Baseline and 12 months
Change in Bone Density
Time frame: Baseline and 12 months
Change in Hormonal Parameters
Time frame: Baseline and 12 months
Change in Coagulation Parameters
Time frame: Baseline and 12 months
Change in hepatic lipid content
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgender Women and HIV/AIDS, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visceral Adipose Tissue (time frame: Baseline and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.