Puberty, Testosterone, and Brain Development
Recruiting · NCT06670053 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
Where it is running
1 location listed across 1 US state.
- Children's Hospital Colorado - Aurora, Colorado, United States