Home › Headache › NCT06670053

Puberty, Testosterone, and Brain Development

Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents

Who can join

Ages 12 to 20 · All sexes

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)

About the study

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.

What is being tested

• Testosterone (drug)

Sponsor: University of Colorado, Denver · Participants: 100 · Started: Dec 31, 2024

Contact the study team

• Jennifer Hranilovich, MD · Phone: (720)-777-6895

Official record on ClinicalTrials.gov — NCT06670053

Locations in the U.S.

Conditions

• Headache
• Migraine

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.