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

Recruiting

• Conditions: Headache; Gender Identity
• Interventions: Other: Clinical estrogen therapy

• Registration Number: NCT05607303
• Lead Sponsor: University of Colorado, Denver

Brief 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.

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.

Study Timeline

• Study Start: 2021-12-14
• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-10-31
• Study First Posted: 2022-11-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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)

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Clinical estrogen therapy	MTF youth who will begin taking estrogen clinically in \< 6 months with or without headache

Primary Outcome Measures

Name	Time	Method
Change in frequency of headache.	1 year	Measured by headache count from daily headache diary.

Secondary Outcome Measures

Name	Time	Method
Change in amygdala structure.	1 year	Amygdala volume as measured on MRI.
Change in resting state functional connectivity pattern.	1 year	Measured by proportion of between-module connectivity patterns vs. within-module connectivity patterns.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States