Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT06670053

Conditions

Gender Identity

Gender Dysphoria in Adolescents and Adults

Headache

Transgender

Eligibility Criteria

Sex: All

Age: 12 - 20

Healthy Volunteers: Not accepted

Interventions

Testosterone

Study Details

Brief 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

Study ID

NCT06670053

Start date

Dec 31, 2024

Status verified date

Apr, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 20

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. transmasculine and gender diverse
2. assigned female at birth
3. age 12-20 years at the time of enrollment
4. plan to start testosterone clinically in < 6 months
5. if taking gonadotropin releasing hormone agonist (GnRHa, puberty blocker), was started on this type of drug 3+ months prior to enrollment

Exclusion Criteria:

1. cognitive or psychiatric impairment resulting in inability to tolerate or perform the study procedures
2. known history of stroke, multiple sclerosis, or other serious neurologic condition
3. prior diagnosis of Turner Syndrome (monosomy X) or other difference of sexual development
4. prior diagnosis of polycystic ovarian syndrome (PCOS)
5. uncontrolled or untreated hypothyroidism
6. MRI-specific exclusion criteria: (Weight > 500 lbs, severe claustrophobia, certain type of metal in body)

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Change in headache burden [ Time Frame: Over the two years of the study ]
  • Amygdala volume [ Time Frame: At the end of the two years of study ]

Central Contacts and Locations

Central contacts

Jennifer Hranilovich, MD

(720)-777-6895headache-research@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Jennifer Hranilovich

720-777-6895headache-research@childrenscolorado.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 3, 2025

Last verified

Apr, 2025

Keywords

  • resting-state functional connectivity
  • pain task
  • fMRI
  • MRI
  • migraine
  • gender affirming hormone therapy
  • testosterone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-04-03.