Puberty, Testosterone, and Brain Development

NCT06670053 | Recruiting

• 1 other identifier: 23-1113
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in headache burden

  Change in number of headache days per month

  Over the two years of the study

• Amygdala volume

  As measured by volumetric MRI

  At the end of the two years of study

Secondary Outcomes (1)

• Headache diagnosis

  At baseline visit before start of T

Study Arms (2)

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.

Drug: Testosterone

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.

Drug: Testosterone

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.

No blocker; On blocker

Eligibility Criteria

• Age: 12 Years - 20 Years
• Gender Eligibility Details: Transmasculine, gender diverse
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

transmasculine and gender diverse youth

You may qualify if:

• 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

You may not qualify if:

• cognitive or psychiatric impairment resulting in inability to tolerate or perform the study procedures
• known history of stroke, multiple sclerosis, or other serious neurologic condition
• prior diagnosis of Turner Syndrome (monosomy X) or other difference of sexual development
• prior diagnosis of polycystic ovarian syndrome (PCOS)
• uncontrolled or untreated hypothyroidism

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Headache; Migraine Disorders

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jennifer Hranilovich

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Hranilovich, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: November 1, 2024
• Study Start: December 31, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)