Actively Recruiting
Puberty, Testosterone, and Brain Development
Led by University of Colorado, Denver · Updated on 2025-04-03
100
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Puberty, Testosterone, and Brain Development
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Transmasculine and gender diverse
- Assigned female at birth
- Age 12 to 20 years at enrollment
- Planning to start testosterone treatment clinically within 6 months
- If taking puberty blockers (GnRHa), started at least 3 months before enrollment
You will not qualify if you...
- Cognitive or psychiatric impairment preventing study participation
- History of stroke, multiple sclerosis, or other 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 exclusion: weight over 500 lbs, severe claustrophobia, or certain types of metal in the body
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
J
Jennifer Hranilovich, MD
CONTACT
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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