Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty (NCT05607303) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty
United States140 participantsStarted 2021-12-14
Plain-language summary
With a rising population of transgender adults and youth, there is a need for more research to meet the needs of this community. Transfemale (MTF) youth (male sex, female gender identity) who begin clinical Gender Affirming Hormone Therapy (GAHT) with estrogen may be at a higher risk for headache since estrogen has been linked to headache in cisgender females (female sex, female gender identity). This research hopes to learn more about headache in MTF youth.
Who can participate
Age range
9 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.