Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
MTF youth who will begin estrogen clinically will be enrolled in the study and will be seen twice, once before starting estrogen and then one year after beginning estrogen. Cisgender males (male sex, male gender identity) will also be enrolled as a control group and will be seen once at the beginning of the study and then once a year later. The researchers will track how often youth have headaches during this time to see if it is different between groups. In a subset of the youth enrolled, an MRI will be completed to also look at brain structure and function.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | MTF youth who will begin taking estrogen clinically in < 6 months with or without headache |
| |
| Controls | Cisgender males with or without headache |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical estrogen therapy | Other | No research interventions will be used as a part of the study since the research is observational. Estrogen treatment will be prescribed and followed by participant's clinical physician. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of headache. | Measured by headache count from daily headache diary. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in amygdala structure. | Amygdala volume as measured on MRI. | 1 year |
| Change in resting state functional connectivity pattern. | Measured by proportion of between-module connectivity patterns vs. within-module connectivity patterns. |
Not provided
Inclusion Criteria:
For MTF youth (cases):
For cisgender male youth (controls):
Exclusion Criteria:
Cognitive, or psychiatric impairment resulting in inability to tolerate the study procedures not including depression or anxiety
Known history of stroke, multiple sclerosis, or other serious neurologic condition
Transfemale (MTF) youth (male sex, female gender identity) and cisgender males (male sex, male gender identity) will be recruited for the study.
Study population is limited to transgender females (male sex, female gender identity) for the case population and cisgender males (male sex, male gender identity) for the purposes of the study analysis as outlined in the protocol.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Hranilovich, MD | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood sample
| 1 year |