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 range9 Years – 20 Years

SexALL

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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)

What they're measuring

Change in frequency of headache.

Timeframe: 1 year

Trial details

NCT IDNCT05607303

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More Headache trials