Actively Recruiting
Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents
Led by University of Colorado, Denver · Updated on 2025-04-03
100
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how testosterone treatment affects headache patterns and brain development in transmasculine youth aged 12 to 20 who are starting gender affirming hormone therapy. This observational study aims to better understand changes in headache burden and brain structure over two years of testosterone use, collecting important information about pain and brain function in this population. Participants will begin testosterone treatment as part of their usual medical care, either with or without prior use of puberty blockers. The study involves four visits: before starting testosterone, after 6 months, after 1 year, and after 2 years of treatment. During these visits, participants will complete health surveys, undergo brain MRI scans, provide blood samples, and have a physical exam at the first visit. Some may also do a brief pain sensitivity test. A headache diary will be kept for selected periods to track headache details and medication use. Participants will be asked to attend morning visits to capture peak hormone levels. Questionnaires will assess anxiety, depression, and headache impact. Medical records will be reviewed for health and medication history. The primary outcomes measured are changes in headache burden and amygdala volume over two years. Secondary outcomes include headache diagnosis at baseline. The study will be conducted at specific research centers, and participation lasts for two years with multiple assessments throughout.
CONDITIONS
Brief Title
Puberty, Testosterone, and Brain Development
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Identify as transmasculine or gender diverse
- Assigned female at birth
- Aged 12 to 20 years at enrollment
- Plan to start testosterone treatment within 6 months
- If using puberty blockers (GnRH agonists), started at least 3 months before enrollment
You will not qualify if you...
- Cognitive or psychiatric impairments preventing study participation
- History of stroke, multiple sclerosis, or serious neurological conditions
- Prior diagnosis of Turner Syndrome or other differences of sexual development
- Prior diagnosis of polycystic ovarian syndrome (PCOS)
- Uncontrolled or untreated hypothyroidism
- MRI exclusions: weight over 500 lbs, severe claustrophobia, or certain metal implants in the body
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants are observed as they begin clinical testosterone therapy prescribed by their own physician. This includes physical exams, hormone level assessments, headache diaries, questionnaires, and brain imaging to monitor changes over time.
Multiple visits including morning visits for peak hormone level measurements and brain imaging sessions
Trial Site Locations
Total: 1 location
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
Jennifer Hranilovich, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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