Clinical trial NCT06670053: Puberty, Testosterone, and Brain Development
Official title: Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gender Identity
Gender Dysphoria in Adolescents and Adults
Headache
Transgender
Keywords: resting-state functional connectivity
pain task
fMRI
MRI
migraine
gender affirming hormone therapy
testosterone
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: transmasculine and gender diverse youth

Brief summary: 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 two years 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 4 visits:

* before starting T
* after 6 months on T
* after 1 year on T
* after 2 years 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, for 1 month after the 1 year visit, and for 1 month after the 2 year visit.

Detailed description: This will be conducted at Childrens Hospital Colorado (CHCO) Clinical \& Translational Research Centers (CTRC) facilities. Physical examination will include vital signs, anthropometric measurements, and breast/pubic hair staging, as applicable, by a medical provider.

Visits will be in the morning to capture peak hormone levels.

The following questionnaires will be administered: PROMIS Pediatric Anxiety Short Form, PROMIS Pediatric Depressive Symptoms Short Form, and PedMIDAS form (headache disability measure).

The daily headache diary is tailored to be brief on days when no headache occurs, and to capture more detail including medications taken and headache and aura characteristics on days a headache does occur.

The medical chart will be reviewed for relevant health information and medications.

MR-based imaging will be conducted at the Brain Imaging Center at the University of Colorado Anschutz Medical Campus.

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)

Primary outcomes:
measure: Change in headache burden
timeFrame: Over the two years of the study
measure: Amygdala volume
timeFrame: At the end of the two years of study
Secondary outcomes:
measure: Headache diagnosis
timeFrame: At baseline visit before start of T
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Jennifer Hranilovich
role: PRINCIPAL_INVESTIGATOR
References: