ACTIVE_NOT_RECRUITING

Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty

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

With a rising population of transgender adults and youth, there is a need for more research to meet the needs of this community. Transfemale (MTF) youth (male sex, female gender identity) who begin clinical Gender Affirming Hormone Therapy (GAHT) with estrogen may be at a higher risk for headache since estrogen has been linked to headache in cisgender females (female sex, female gender identity). This research hopes to learn more about headache in MTF youth.

Official Title

Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty

Quick Facts

Study Start:2021-12-14
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05607303

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:9 Years to 20 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Identify as MTF
  2. * Age 11-20 years at the time of enrollment
  3. * Plan to start estrogen clinically in \< 6 months
  4. * Identify as cisgender male
  5. * Age 9-20 years at the time of enrollment
  6. * No diagnosis of Klinefelter Syndrome (XXY)
  1. * Cognitive, or psychiatric impairment resulting in inability to tolerate the study procedures not including depression or anxiety
  2. * Known history of stroke, multiple sclerosis, or other serious neurologic condition
  3. * MRI-specific exclusion criteria (Weight \> 500 lbs, claustrophobia, metal in body)

Contacts and Locations

Principal Investigator

Jennifer Hranilovich, MD
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, MD, 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 Date2021-12-14
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2021-12-14
Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Headache
  • Gender Identity