Puberty, Testosterone, and Brain Development
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-20
SponsorUniversity of Colorado, Denver
About this trial
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 year 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 3 visits:
* before starting T * after 6 months on T * after 1 year 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 and for 1 month after the 1 year visit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
transmasculine and gender diverse youth
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Testosterone
DrugClinical 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: On blocker1 intervention
Group B: No blocker1 intervention
Trial outcomes
Primary outcomes
1
Change in headache burden
Change in number of headache days per month
Time frame
Over the one year of the study2
Amygdala volume
As measured by volumetric MRI
Time frame
At the end of the one year of studySecondary outcomes
1
Headache diagnosis
Application of ICHD-3 criteria to headaches, if any
Time frame
At baseline visit before start of TSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov