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NCT04128488 · ClinicalTrials.gov registry record
Effects of Gender-Affirming Hormone Therapy Among Transgender Women
A clinical trial, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 33
- Enrollment target
NCT04128488: Completed study, sponsored by Massachusetts General Hospital.
NCT04128488 is a clinical trial that has completed, run by Massachusetts General Hospital. The registered enrollment target is 33 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04128488 has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 33 participants
- Enrollment target
Study 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.
Interventions
- OTHER Cardiac MRI/MRS
- OTHER Abdominal MR Imaging
- OTHER Oral Glucose Tolerance Testing
- OTHER Whole Body, Lumbar Spine, and Hip DEXA Imaging
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2024-03-28 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04128488
The ClinicalTrials.gov registry entry for NCT04128488 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cardiac MRI/MRS is the first listed.
NCT04128488 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04128488 about?
NCT04128488 is a clinical study titled "Effects of Gender-Affirming Hormone Therapy Among Transgender Women". 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 mo...
What is the current status of trial NCT04128488?
This trial is currently completed. The enrollment target is 33 participants. The study started on 2019-11-01. Estimated completion is 2024-03-28.
What interventions are being tested in trial NCT04128488?
The interventions under investigation include: Cardiac MRI/MRS (OTHER), Abdominal MR Imaging (OTHER), Oral Glucose Tolerance Testing (OTHER), Whole Body, Lumbar Spine, and Hip DEXA Imaging (OTHER).
Who is sponsoring clinical trial NCT04128488?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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