NCT05607303

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 9 Years – 20 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-14
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2022-11-07
• Last updated: 2025-07-04

Locations

1 site across 1 country: United States