Children's Hospital Colorado
Aurora, Colorado, 80045, United States
Location status: Recruiting
NCT Number: NCT06670053
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.
Interested in participating?
Request Info12 year–20 year
All sexes
Observational
Aurora, Colorado, 80045, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Over the two years of the study
Change in number of headache days per month
Time frame: At the end of the two years of study
As measured by volumetric MRI
Time frame: At baseline visit before start of T
Application of ICHD-3 criteria to headaches, if any
Contact information is provided by the study sponsor or research team.
University of Colorado, Denver
Other
Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05607303
Gender Identity, Headache
Aurora, Colorado, United States
View Trial DetailsNCT04237467
Appetitive Behavior, Behavior
Aurora, Colorado, United States
View Trial DetailsNCT05195164
Appetitive Behavior, Behavior
Aurora, Colorado, United States
View Trial DetailsNCT04066283
Appetitive Behavior, Behavior
Aurora, Colorado, United States
View Trial Details