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

NCT ID: NCT05607303

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-14
• Study Completion Date: 2026-06-30

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.

Conditions

Headache; Gender Identity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases

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

Clinical estrogen therapy

Intervention Type: OTHER

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.

Controls

Cisgender males with or without headache

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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 &lt; 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

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Hranilovich, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

20-1824

Identifier Type: -

Identifier Source: org_study_id