Study of Testosterone Effects on Brain and Headaches in Transmasculine Youth Ages 12 to 20

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.

Puberty, Testosterone, and Brain Development