MedTrace Logo

Puberty, Testosterone, and Brain Development

NCT06670053 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-04-03

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Testosterone

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.

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Jennifer Hranilovich · Children's Hospital Colorado

Eligibility

Min Age
12 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06670053 on ClinicalTrials.gov