An observational study in Gender Identity, Gender Dysphoria in Adolescents and Adults and Headache, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 12 Years to 20 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University of Colorado, Denver · Observational
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:
At the visits, they will be asked to:
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.
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.
762 studies on the registry are indexed under Headache; 134 are open to participants now.
This study's planned enrollment of 100 is below the median of 139 across 168 observational studies indexed under Headache.
Browse Headache studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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transmasculine and gender diverse youth
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Transmasculine youth who will begin taking testosterone clinically in \< 6 months with or without headache and who have been on pubertal blocker, a gonadotropin hormone releasing (GnRH) agonist for at least 3 months.
Drug: Testosterone
Transmasculine youth who will begin taking testosterone clinically in \< 6 months with or without headache and who have no history of pubertal blocker.
Drug: Testosterone
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.
Change in headache burden
Change in number of headache days per month
Time frame: Over the one year of the study
Amygdala volume
As measured by volumetric MRI
Time frame: At the end of the one year of study
Headache diagnosis
Application of ICHD-3 criteria to headaches, if any
Time frame: At baseline visit before start of T
Plan to share: No
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