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

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607303
• Other study ID #: 20-1824
• Status: Recruiting
• Start date: December 14, 2021
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: Emily Albertson
• Phone: 720-777-9941
• Email: emily.albertson[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 20 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gender Identity
• Headache

Intervention

Other:
• Clinical estrogen therapy
No research interventions will be used as a part of the study since the research is observational. Estrogen treatment will be prescribed and followed by participant's clinical physician.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in frequency of headache.	Measured by headache count from daily headache diary.	1 year
Secondary	Change in amygdala structure.	Amygdala volume as measured on MRI.	1 year
Secondary	Change in resting state functional connectivity pattern.	Measured by proportion of between-module connectivity patterns vs. within-module connectivity patterns.	1 year