HeadacheNCT05607303
Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty
An observational study of Headache and Gender Identity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 9 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache, Gender Identity
- What is being tested?
- Clinical estrogen therapy
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 30 Jun 2027
- 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 9 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 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.
Who may be able to join
- For MTF youth (cases):
- Identify as MTF
- Age 11-20 years at the time of enrollment
- Plan to start estrogen clinically in \< 6 months
- For cisgender male youth (controls):
- Identify as cisgender male
- Age 9-20 years at the time of enrollment
- No diagnosis of Klinefelter Syndrome (XXY)
Who cannot join
- 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
- MRI-specific exclusion criteria (Weight \> 500 lbs, claustrophobia, metal in body)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
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.
Read the detailed description
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.
- Conditions
- Headache, Gender Identity
- Being tested
- Clinical estrogen therapy
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical estrogen therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | MTF youth who will begin taking estrogen clinically in < 6 months with or without headache Receives: Other: Clinical estrogen therapy | |
| Controls | Cisgender males with or without headache |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of headache.
Measured by headache count from daily headache diary.
Measured: 1 year
Secondary outcomes (2)
Change in amygdala structure.
Amygdala volume as measured on MRI.
Measured: 1 year
Change in resting state functional connectivity pattern.
Measured by proportion of between-module connectivity patterns vs. within-module connectivity patterns.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start14 Dec 2021
- Primary completion30 Jun 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Hranilovich, MD, Principal investigator, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607303
- Sponsor's protocol ID
- 20-1824
- Status last verified
- Sep 2026
- First submitted
- 31 Oct 2022
- Last updated
- 16 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hormones on Frequency of Headache and Brain Structure and Function in Puberty
- ClinicalTrials.gov ID
- NCT05607303
- Acronym / sponsor ID
- 20-1824
- Conditions
- Headache, Gender Identity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Nov 2022 (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.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Clinical estrogen therapyMTF youth who will begin taking estrogen clinically in < 6 months with or without headache |
| Controls | – | –Cisgender males with or without headache |
Who may qualify
- Ages
- 9 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- Identify as MTF
- Age 11-20 years at the time of enrollment
- Plan to start estrogen clinically in \< 6 months
- Identify as cisgender male
- Age 9-20 years at the time of enrollment
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Clinical estrogen therapyNo 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. | Other | Cases |
Primary outcome
Change in frequency of headache.
Time frame: 1 year
Measured by headache count from daily headache diary.
2 secondary outcomes
Change in amygdala structure.
Time frame: 1 year
Change in resting state functional connectivity pattern.
Time frame: 1 year
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 16 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. This study is not recruiting at the moment.
Jennifer Hranilovich, MD 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 Headache and Gender Identity, 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 8 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 16 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of headache. (time frame: 1 year). 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 16 Sep 2026.