Effects of testosterone on headaches and brain development in transmasculine youth

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the impact of testosterone therapy on headache patterns and brain development in transmasculine youth aged 12-20 who are assigned female at birth. Participants will undergo a series of assessments, including health surveys, brain MRIs, and blood samples, at four different time points: before starting testosterone and after 6 months, 1 year, and 2 years of treatment. The study aims to understand how testosterone influences headache experiences and brain structure during the initial years of hormone therapy. The research is conducted at Children's Hospital Colorado and involves close monitoring of participants' health and well-being.

Why it matters

Who can join: the full rules

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)

Where it's running

• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting

Study contacts

• Principal investigator: Jennifer Hranilovich — Children's Hospital Colorado
• Study coordinator: Jennifer Hranilovich, MD
• Email: headache-research@childrenscolorado.org
• Phone: (720)-777-6895

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.