Effects of testosterone on headaches and brain development in transmasculine youth
Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents
University of Colorado, Denver · NCT06670053
This study is testing how testosterone therapy affects headaches and brain development in transmasculine youth aged 12-20 who were assigned female at birth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 12 Years to 20 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06670053 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are transmasculine youth aged 12-20 who are assigned female at birth and plan to start testosterone therapy within the next 6 months.
Not a fit: Patients with cognitive or psychiatric impairments, serious neurological conditions, or specific MRI exclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into managing headaches and improving brain health in transmasculine youth undergoing hormone therapy.
How similar studies have performed: While studies have explored the effects of testosterone on pain in cisgender females and transmasculine adults, this specific approach in transmasculine youth is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Aurora, Colorado
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gender Identity, Gender Dysphoria in Adolescents and Adults, Headache, Transgender, resting-state functional connectivity, pain task, fMRI, MRI