Puberty, Testosterone, and Brain Development
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Testosterone.
- Who it may be relevant to
- Registry conditions: Gender Identity, Gender Dysphoria in Adolescents and Adults, Headache, Transgender. Basic parameters: 12 years — 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents
Overview
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.
Interventions
- Drug Testosterone
Clinical testosterone therapy No research interventions will be used as a part of the study since the research is observational. Testosterone treatment will be prescribed and followed by participant's clinical physician.
Primary outcome measures
- Change in headache burden [Time frame: Over the two years of the study]
- Amygdala volume [Time frame: At the end of the two years of study]
Secondary outcome measures (1)
- Headache diagnosis [Time frame: At baseline visit before start of T]
Eligibility criteria
Inclusion criteria
- transmasculine and gender diverse
- assigned female at birth
- age 12-20 years at the time of enrollment
- plan to start testosterone clinically in < 6 months
- if taking gonadotropin releasing hormone agonist (GnRHa, puberty blocker), was started on this type of drug 3+ months prior to enrollment
Exclusion criteria
- cognitive or psychiatric impairment resulting in inability to tolerate or perform the study procedures
- known history of stroke, multiple sclerosis, or other serious neurologic condition
- prior diagnosis of Turner Syndrome (monosomy X) or other difference of sexual development
- prior diagnosis of polycystic ovarian syndrome (PCOS)
- uncontrolled or untreated hypothyroidism
- MRI-specific exclusion criteria: (Weight > 500 lbs, severe claustrophobia, certain type of metal in body)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Children's Hospital Colorado — Aurora
Identifiers
NCT: NCT06670053 · 23-1113