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

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Gender Identity; Headache

Treatments: Other: Clinical estrogen therapy

Study type: Observational

Funder types: Other

Identifiers

NCT05607303

20-1824

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 9 to 20 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

140 participants in 2 patient groups

Cases

Description:

MTF youth who will begin taking estrogen clinically in \< 6 months with or without headache

Treatment:

Other: Clinical estrogen therapy

Controls

Description:

Cisgender males with or without headache