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Puberty, Testosterone, and Brain Development

Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 20 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 1 visit
  • Time periods mentioned: 1 month
  • Procedures mentioned: Physical exams, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "All participants will be asked to complete a headache diary for the first 6 months and for 1 month after the 1 year visit."
  • "Physical examination will include vital signs, anthropometric measurements, and breast/pubic hair staging, as applicable, by a medical provider."
  • "The following questionnaires will be administered: PROMIS Pediatric Anxiety Short Form, PROMIS Pediatric Depressive Symptoms Short Form, and PedMIDAS form (headache disability measure)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how headaches and brain structure and function change during the first year of testosterone treatment. It is for transmasculine and gender-diverse youth ages 12–20 who were assigned female at birth and plan to start testosterone in less than 6 months as part of their regular care.

Transmasculine youth (female sex assigned at birth, male gender identity) who begin clinical gender affirming hormone therapy (GAHT) with testosterone (T) may experience changes in headache. Researchers think this because studies published on effects of giving testosterone to cisgender females (female sex, female gender identity) and transmasculine adults seem to show an effect on pain. This research will help us learn more about changes in headache and in brain structure and function in transmasculine youth during the first year of T. Youth who will be starting T within 6 months, either on puberty blocker or not, as part of their regular medical care can participate and will be asked to attend 3 visits: * before starting T * after 6 months on T * after 1 year on T At the visits, they will be asked to: * answer questions and surveys about their health * have a brain MRI done * give a small sample of blood and at their first visit, complete a physical exam. Some participants can also do a brief test of pain sensitivity. All participants will be asked to complete a headache diary for the first 6 months and for 1 month after the 1 year visit.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are transmasculine or gender diverse.
  • You were assigned female at birth.
  • You are 12–20 years old when you join.
  • You plan to start testosterone through your medical care in less than 6 months.
  • If you take a GnRHa puberty blocker, a medicine that pauses puberty, you started it at least 3 months before joining.

Who can't join

  • A thinking or mental health condition keeps you from completing or handling the study tests.
  • You have a history of stroke, multiple sclerosis, or another serious brain or nerve condition.
  • You have been diagnosed with Turner syndrome, a condition involving a missing X chromosome, or another difference in sex development.
  • You have been diagnosed with polycystic ovarian syndrome (PCOS), a hormone condition that affects the ovaries.
  • You have an underactive thyroid that is untreated or not controlled.
  • You weigh more than 500 pounds, have a severe fear of small spaces, or have certain types of metal in your body that prevent an MRI scan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. transmasculine and gender diverse 2. assigned female at birth 3. age 12-20 years at the time of enrollment 4. plan to start testosterone clinically in \< 6 months 5. if taking gonadotropin releasing hormone agonist (GnRHa, puberty blocker), was started on this type of drug 3+ months prior to enrollment Exclusion Criteria: 1. cognitive or psychiatric impairment resulting in inability to tolerate or perform the study procedures 2. known history of stroke, multiple sclerosis, or other serious neurologic condition 3. prior diagnosis of Turner Syndrome (monosomy X) or other difference of sexual development 4. prior diagnosis of polycystic ovarian syndrome (PCOS) 5. uncontrolled or untreated hypothyroidism 6. MRI-specific exclusion criteria: (Weight \> 500 lbs, severe claustrophobia, certain type of metal in body)

Study sites (1)

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