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

NCT05607303 | Active Not Recruiting

• 1 other identifier: 20-1824
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Gender Identity

Outcome Measures

Primary Outcomes (1)

• Change in frequency of headache.

  Measured by headache count from daily headache diary.

  1 year

Secondary Outcomes (2)

• Change in amygdala structure.

  1 year

• Change in resting state functional connectivity pattern.

  1 year

Study Arms (2)

Cases

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

Other: Clinical estrogen therapy

Controls

Cisgender males with or without headache

Interventions

Clinical estrogen therapy 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.

Cases

Eligibility Criteria

• Age: 9 Years - 20 Years
• Gender Eligibility Details: Transfemale (MTF) youth (male sex, female gender identity) and cisgender males (male sex, male gender identity) will be recruited for the study.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Hranilovich, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 7, 2022
• Study Start: December 14, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)