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OpenTrials
Active, Not Recruiting

NCT Number: NCT05607303

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

9 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Change in frequency of headache.

    Time frame: 1 year

    Measured by headache count from daily headache diary.

Secondary outcomes

  1. Change in amygdala structure.

    Time frame: 1 year

    Amygdala volume as measured on MRI.

  2. Change in resting state functional connectivity pattern.

    Time frame: 1 year

    Measured by proportion of between-module connectivity patterns vs. within-module connectivity patterns.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2022
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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