Puberty, Testosterone, and Brain Development

Launched by UNIVERSITY OF COLORADO, DENVER · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Puberty, Testosterone, and Brain Development," is studying how starting testosterone hormone therapy affects headaches and brain development in transmasculine youth—those assigned female at birth but who identify as male. Researchers want to understand if testosterone impacts headaches in young people, similar to what has been observed in adults and cisgender females. The study will follow participants for two years after they start testosterone, looking closely at changes in their health and brain through surveys, MRIs (which are detailed brain scans), and blood samples.

To be eligible for this study, participants must be transmasculine or gender diverse, aged 12 to 20, and planning to start testosterone therapy within the next six months. They should also have been on a puberty blocker for at least three months if they are taking one. Participants will have four visits during the study: one before starting testosterone and three follow-ups at six months, one year, and two years. During these visits, they will answer health questions, undergo brain scans, and keep a headache diary for the first six months and for a month after each annual visit. This research aims to provide valuable insights into the effects of testosterone on headaches and brain changes in young people.

Gender

ALL

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)