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Recruiting

NCT Number: NCT06670053

Puberty, Testosterone, and Brain Development

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.

Recruiting

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Key information

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Jennifer Hranilovich

CONTACT

[email protected]

720-777-6895

About this study

This will be conducted at Childrens Hospital Colorado (CHCO) Clinical & Translational Research Centers (CTRC) facilities. Physical examination will include vital signs, anthropometric measurements, and breast/pubic hair staging, as applicable, by a medical provider.

Visits will be in the morning to capture peak hormone levels.

The following questionnaires will be administered: PROMIS Pediatric Anxiety Short Form, PROMIS Pediatric Depressive Symptoms Short Form, and PedMIDAS form (headache disability measure).

The daily headache diary is tailored to be brief on days when no headache occurs, and to capture more detail including medications taken and headache and aura characteristics on days a headache does occur.

The medical chart will be reviewed for relevant health information and medications.

MR-based imaging will be conducted at the Brain Imaging Center at the University of Colorado Anschutz Medical Campus.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • MRI-specific exclusion criteria: (Weight > 500 lbs, severe claustrophobia, certain type of metal in body)

Treatment and study plan

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.

Primary outcomes

  1. Change in headache burden

    Time frame: Over the two years of the study

    Change in number of headache days per month

  2. Amygdala volume

    Time frame: At the end of the two years of study

    As measured by volumetric MRI

Secondary outcomes

  1. Headache diagnosis

    Time frame: At baseline visit before start of T

    Application of ICHD-3 criteria to headaches, if any

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Hranilovich, MD

CONTACT

[email protected]

(720)-777-6895

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2024
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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