Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-12-31
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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On blocker
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.
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.
No blocker
Transmasculine youth who will begin taking testosterone clinically in \< 6 months with or without headache and who have no history of pubertal blocker.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. assigned female at birth
3. age 12-20 years at the time of enrollment
4. plan to start testosterone clinically in \< 6 months
5. if taking gonadotropin releasing hormone agonist (GnRHa, puberty blocker), was started on this type of drug 3+ months prior to enrollment
Exclusion Criteria
2. known history of stroke, multiple sclerosis, or other serious neurologic condition
3. prior diagnosis of Turner Syndrome (monosomy X) or other difference of sexual development
4. prior diagnosis of polycystic ovarian syndrome (PCOS)
5. uncontrolled or untreated hypothyroidism
12 Years
20 Years
ALL
No
Sponsors
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University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Jennifer Hranilovich
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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23-1113
Identifier Type: -
Identifier Source: org_study_id
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