Puberty, Testosterone, and Brain Development

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06670053
Status
Recruiting
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Conditions

  • Gender Dysphoria in Adolescents and Adults
  • Gender Identity
  • Headache
  • Transgender

Eligibility Criteria

Sex
ALL
Age
12 Years - 20 Years
Healthy Volunteers
Not accepted

Interventions

  • Testosterone — DRUG
    Clinical testosterone therapy No research interventions will be used as a part of the study since the research is observational. Testosterone treatment will be prescribed and followed by participant's clinical physician.

Study Details

Transmasculine youth (female sex assigned at birth, male gender identity) who begin clinical gender affirming hormone therapy (GAHT) with testosterone (T) may experience changes in headache. Researchers think this because studies published on effects of giving testosterone to cisgender females (female sex, female gender identity) and transmasculine adults seem to show an effect on pain. This research will help us learn more about changes in headache and in brain structure and function in transmasculine youth during the first two years of T. Youth who will be starting T within 6 months, either on puberty blocker or not, as part of their regular medical care can participate and will be asked to attend 4 visits: * before starting T * after 6 months on T * after 1 year on T * after 2 years on T At the visits, they will be asked to: * answer questions and surveys about their health * have a brain MRI done * give a small sample of blood and at their first visit, complete a physical exam. Some participants can also do a brief test of pain sensitivity. All participants will be asked to complete a headache diary for the first 6 months, for 1 month after the 1 year visit, and for 1 month after the 2 year visit.

Key Dates

Start date
Dec 31, 2024
Status verified
Apr 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: On blocker
    Transmasculine youth who will begin taking testosterone clinically in \< 6 months with or without headache and who have been on pubertal blocker, a gonadotropin hormone releasing (GnRH) agonist for at least 3 months.
  • Arm: No blocker
    Transmasculine youth who will begin taking testosterone clinically in \< 6 months with or without headache and who have no history of pubertal blocker.

Primary Outcome Measure

Change in headache burden [ Time Frame: Over the two years of the study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Jennifer Hranilovich
[email protected]
720-777-6895

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By research site
Children's Hospital Colorado· Aurora, CO

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