Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 20
Healthy Volunteers: f
View:

• transmasculine and gender diverse

• assigned female at birth

• age 12-20 years at the time of enrollment

• plan to start testosterone clinically in \< 6 months

• if taking gonadotropin releasing hormone agonist (GnRHa, puberty blocker), was started on this type of drug 3+ months prior to enrollment

Locations
United States
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Contact Information
Primary
Jennifer Hranilovich, MD
headache-research@childrenscolorado.org
(720)-777-6895
Time Frame
Start Date: 2024-12-31
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov