RECRUITING

Puberty, Testosterone, and Brain Development

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents

Quick Facts

Study Start:2024-12-31
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06670053

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. transmasculine and gender diverse
  2. 2. assigned female at birth
  3. 3. age 12-20 years at the time of enrollment
  4. 4. plan to start testosterone clinically in \< 6 months
  5. 5. if taking gonadotropin releasing hormone agonist (GnRHa, puberty blocker), was started on this type of drug 3+ months prior to enrollment
  1. 1. cognitive or psychiatric impairment resulting in inability to tolerate or perform the study procedures
  2. 2. known history of stroke, multiple sclerosis, or other serious neurologic condition
  3. 3. prior diagnosis of Turner Syndrome (monosomy X) or other difference of sexual development
  4. 4. prior diagnosis of polycystic ovarian syndrome (PCOS)
  5. 5. uncontrolled or untreated hypothyroidism
  6. 6. MRI-specific

Contacts and Locations

Study Contact

Jennifer Hranilovich, MD
CONTACT
(720)-777-6895
headache-research@childrenscolorado.org

Principal Investigator

Jennifer Hranilovich
PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80045
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Jennifer Hranilovich, PRINCIPAL_INVESTIGATOR, Children's Hospital Colorado

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-31
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-12-31
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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