Impact of Hormones on Headaches and Brain Health in Transgender Youth
Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty
This study looks at how starting estrogen therapy affects headaches and brain health in transgender girls compared to cisgender boys over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 9 Years to 20 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05607303 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the frequency of headaches and changes in brain structure and function among transgender female youth who are starting estrogen therapy. Participants will be assessed twice: once before beginning hormone therapy and again one year later. A control group of cisgender males will also be included to compare headache frequency. Additionally, a subset of participants will undergo MRI scans to evaluate brain changes associated with hormone therapy.
Who should consider this trial
Good fit: Ideal candidates include transgender female youth aged 11-20 who plan to start estrogen therapy within the next six months.
Not a fit: Patients with cognitive or psychiatric impairments that prevent them from participating, or those with serious neurological conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the relationship between hormone therapy and headache prevalence in transgender youth, potentially leading to better management strategies.
How similar studies have performed: While there is limited research specifically on this population, studies have shown that hormonal changes can affect headache patterns in cisgender females, suggesting potential relevance for this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: For MTF youth (cases): * Identify as MTF * Age 11-20 years at the time of enrollment * Plan to start estrogen clinically in \< 6 months For cisgender male youth (controls): * Identify as cisgender male * Age 9-20 years at the time of enrollment * No diagnosis of Klinefelter Syndrome (XXY) Exclusion Criteria: * Cognitive, or psychiatric impairment resulting in inability to tolerate the study procedures not including depression or anxiety * Known history of stroke, multiple sclerosis, or other serious neurologic condition * MRI-specific exclusion criteria (Weight \> 500 lbs, claustrophobia, 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, MD — 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.