Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty

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Description

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.

Targeted Conditions

Study Overview

Start Date
December 14, 2021
Completion Date
June 1, 2025
Enrollment
140
Date Posted
November 7, 2022
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
Children's Hospital Colorado
Aurora, Colorado 80045, United States

Eligibility

Study Population
Study population is limited to transgender females (male sex, female gender identity) for the case population and cisgender males (male sex, male gender identity) for the purposes of the study analysis as outlined in the protocol.
Minimum Age (years)
9
Maximum Age (years)
20
Eligibility 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)

Study Contact Info

Study Contact Name
Emily Albertson; Lauren Mitchell
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
Detailed Description
MTF youth who will begin estrogen clinically will be enrolled in the study and will be seen twice, once before starting estrogen and then one year after beginning estrogen. Cisgender males (male sex, male gender identity) will also be enrolled as a control group and will be seen once at the beginning of the study and then once a year later. The researchers will track how often youth have headaches during this time to see if it is different between groups. In a subset of the youth enrolled, an MRI will be completed to also look at brain structure and function.
NCTid (if applicable)
NCT05607303