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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05607303
Enrollment
138
Registered
2022-11-07
Start date
2021-12-14
Completion date
2027-06-30
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gender Identity, Headache

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.

Interventions

OTHERClinical 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.

Sponsors

University of Colorado, Denver
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
9 Years to 20 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in frequency of headache.1 yearMeasured by headache count from daily headache diary.

Secondary

MeasureTime frameDescription
Change in amygdala structure.1 yearAmygdala volume as measured on MRI.
Change in resting state functional connectivity pattern.1 yearMeasured by proportion of between-module connectivity patterns vs. within-module connectivity patterns.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJennifer Hranilovich, MD

Children's Hospital Colorado

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026