Gender IdentityNCT06670053
Puberty, Testosterone, and Brain Development
An observational study of Gender Identity and Gender Dysphoria in Adolescents and Adults, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Gender Identity, Gender Dysphoria in Adolescents and Adults, Headache
- What is being tested?
- Testosterone
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2024to Jan 2029
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: transmasculine and gender diverse youth
Who may be able to join
- 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
- if taking gonadotropin releasing hormone agonist (GnRHa, puberty blocker), was started on this type of drug 3+ months prior to enrollment
Who cannot join
- 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)
- uncontrolled or untreated hypothyroidism
- MRI-specific exclusion criteria: (Weight > 500 lbs, severe claustrophobia, certain type of metal in body)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Jennifer Hranilovich, 720-777-6895, headache-research@childrenscolorado.org
About this study
Official title: Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents
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:
Read more
- 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.
Read the detailed description
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.
- Being tested
- Testosterone
- Keywords
- resting-state functional connectivity, pain task, fMRI, MRI, migraine, gender affirming hormone therapy, testosterone
- Medical subject headings
- Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Testosterone | |
| 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. Receives: Drug: Testosterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in headache burden
Change in number of headache days per month
Measured: Over the one year of the study
Amygdala volume
As measured by volumetric MRI
Measured: At the end of the one year of study
Secondary outcomes (1)
Headache diagnosis
Application of ICHD-3 criteria to headaches, if any
Measured: At baseline visit before start of T
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start31 Dec 2024
- Primary completionJun 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender IdentityStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Hranilovich, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670053
- Sponsor's protocol ID
- 23-1113
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Testosterone on Brain Imaging and Headache in Transmasculine Adolescents
- ClinicalTrials.gov ID
- NCT06670053
- Acronym / sponsor ID
- 23-1113
- Keywords
- resting-state functional connectivity, pain task, fMRI, MRI, migraine, gender affirming hormone therapy, testosterone
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On blocker | – | Drug: TestosteroneTransmasculine 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. |
| No blocker | – | Drug: TestosteroneTransmasculine youth who will begin taking testosterone clinically in < 6 months with or without headache and who have no history of pubertal blocker. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- transmasculine and gender diverse youth
Key inclusion criteria (5 listed)
- 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
- if taking gonadotropin releasing hormone agonist (GnRHa, puberty blocker), was started on this type of drug 3+ months prior to enrollment
Key exclusion criteria (6 listed)
- 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)
- uncontrolled or untreated hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestosteroneClinical 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. | Drug | No blocker, On blocker |
Primary outcome
Change in headache burden
Time frame: Over the one year of the study
Change in number of headache days per month
Amygdala volume
Time frame: At the end of the one year of study
As measured by volumetric MRI
1 secondary outcome
Headache diagnosis
Time frame: At baseline visit before start of T
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Hranilovich principal investigator
Children's Hospital Colorado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Identity and Gender Dysphoria in Adolescents and Adults, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Hranilovich, MD ((720)-777-6895, headache-research@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in headache burden (time frame: Over the one year of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.