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Testosterone Therapy's heart risks under the microscope for transgender youth

NCT ID NCT04977765

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how testosterone therapy changes heart and metabolic health in transgender boys and men aged 12 to 30. Researchers will measure blood vessel function, blood pressure, and body composition over one year. The goal is to understand any risks and whether starting therapy before or after puberty makes a difference.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

EXCLUSION CRITERIA FOR TRANSGENDER AND CISGENDER INDIVIDUALS 1. Any disease affecting glucose, sex steroid, or fat metabolism such as diabetes, polycystic ovary syndrome, or clinical suspicion of insulin resistance) 2. Any medication use that may affect glucose, sex steroid, or fat metabolism such as metformin or glucocorticoids 3. Known cardiovascular disease such as hypertension or atherosclerosis 4. Raynaud's phenomenon or other vascular disease 5. BMI \> 40 kg/m2 for those aged ≥ 18 years or \> 95% percentile for age- and sex-assigned at birth in those aged \< 18 years 6. Pregnancy or lactation 7. Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results.

Ages

12 to 30 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * INCLUSION CRITERIA FOR TRANSGENDER BOYS AND TRANSGENDER MEN 1. Sex assigned female at birth and a male gender identity (i.e., transgender male) 2. Aged 12-30 years 3. Have a care provider in the Children's Wisconsin Gender Health Clinic or Froedtert Hospital Inclusion Clinic who has determined the individual meets clinical criteria to start testosterone therapy and plans to initiate this therapy 4. Naïve to testosterone or other masculinizing medical therapy 5. Cisgender girls/women and transgender boys/men of child-bearing potential (defined as having achieved menarche (first menses), excluding those who have had a hysterectomy or are on GnRH agonist therapy (puberty blockers)) must be willing to use effective birth control (which may include abstinence)) from screening visit until final study visit 6. Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is \< 18 years of age INCLUSION CRITERIA FOR CISGENDER INDIVIDUALS 1. Gender identity concordant with sex assigned at birth (i.e., cisgender) 2. Aged 12-30 years 3. Not related to a transgender participant enrolled in the study 4. Naïve to any sex hormone or pubertal blocker therapy or, specific to cisgender girls/women only, must be ≥ 1 year from use of oral contraceptive or other contraceptive technique (intrauterine device, medroxyprogesterone injections) 5. Willing and able to give informed consent or have parent or legal guardian provide informed consent if the subject is \< 18 years of age INCLUSION CRITERIA FOR OPTIONAL NITROGLYCERIN ENDOTHELIUM-INDEPENDENT VASCULAR FUNCTION STUDY 1. Aged ≥ 18 years 2. No history of migraine headaches 3. Systolic blood pressure ≥ 110 mm Hg 4. No prior past adverse reaction to nitroglycerin 5. Has not used a PDE5 inhibitor (i.e., sildenafil, tadalafil, vardenafil) in the past 7 days Exclusion Criteria: \-

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Conditions

The condition(s) this trial relates to.

Transsexualism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.