Gender DysphoriaNCT04374708
Gender Identity and Own Body Perception
An observational study of Gender Dysphoria, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will provide valuable information on the neurobiological underpinning of gender dysphoria (GD) and the effects of sex hormones, and promises to uncover functional or structural neural patterns that could predict outcome in terms of body image and quality of life after cross-sex hormone treatment. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender Dysphoria
- What is being tested?
- fMRI
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Investigators will enroll 150 participants between the ages of 18 and 40 (25 trans males; 25 trans females; 25 cis gender females; 25 cis gender males; 25 homosexual males; 25 homosexual females)
Who may be able to join
- Females and males from any racial or ethnic background, between the ages of 18 years and 40 years.
- Participants must meet Diagnostic and Statistical Manual-5 criteria for GD (302.85)
- Intelligence quotient (IQ) > 80
- Participants with GD
- Females and males from any racial or ethnic background, between the ages of 18 and 40.
- IQ > 80
- Control participants
Who cannot join
- Previous or on-going sex hormone medication
- Previous sex reassignment surgery
- Oral contraceptives
- Participants with GD are not be taking any other psychotropic medication. (No participant will be recommended to discontinue or taper medications for the purpose of participating in the study.)
- Irregular menstrual cycles
- Control participants
Show all 19Show fewer
- Psychiatric medications
- A score of ≥ 1 standard deviation higher than population norms on the MADRS depression or the Hamilton anxiety scale (HAMA)
- Sex hormone treatment
- Irregular menstrual cycles
- Any known chromosomal or hormonal disorder
- Current substance abuse or dependence
- Current neurological disorder or psychiatric disorder
- Pregnancy
- Current major medical disorders that may affect cerebral metabolism such as diabetes or thyroid disorders
- Head trauma associated with loss of consciousness
- HIV positive individuals
- Individuals with ferromagnetic metal implantations or devices. This includes any electronic implants or devices, braces, infusion pumps, aneurysm clips, metal fragments or foreign bodies, metal prostheses, joints, rods or plates
- Visual acuity worse than 20/35 for each eye as determined by Snellen close vision acuity chart. Acuity may be met with corrective lenses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gender Identity and Own Body Perception- Implications for the Neurobiology of Gender Dysphoria
This study will provide valuable information on the neurobiological underpinning of gender dysphoria (GD) and the effects of sex hormones, and promises to uncover functional or structural neural patterns that could predict outcome in terms of body image and quality of life after cross-sex hormone treatment.
Read the detailed description
The purpose of this study is to understand the neurobiology of gender dysphoria (GD) and the interactions between cross hormone treatment, the brain, and the body phenotype. The investigators also aim to identify pre-treatment neurobiological and other factors to help predict body congruence and quality of life outcomes from hormone treatment. There is mounting interest in gender identity issues worldwide, as requests for gender-confirming treatments have increased in the past 3 decades, and alarmingly high suicide rates have recently been reported in those with GD. Despite this, little is known about neurobiological or other etiological factors contributing to GD or gender incongruence. This study will address a core feature of GD that has been little studied in terms of the neurobiology: the incongruence between perception of self and one's own body.
- Conditions
- Gender Dysphoria
- Being tested
- fMRI
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIDiagnostic test
fMRI: body morph test and neurocognitive testing
| Study group | Role | What they receive |
|---|---|---|
| trans men | fMRI: body morph test and neurocognitive testing Receives: Diagnostic Test: fMRI | |
| trans women | fMRI: body morph test and neurocognitive testing Receives: Diagnostic Test: fMRI | |
| homosexual cisgender men | fMRI: body morph test and neurocognitive testing Receives: Diagnostic Test: fMRI | |
| homosexual cisgender women | fMRI: body morph test and neurocognitive testing Receives: Diagnostic Test: fMRI | |
| cisgender women | fMRI: body morph test and neurocognitive testing Receives: Diagnostic Test: fMRI | |
| cisgender men | fMRI: body morph test and neurocognitive testing Receives: Diagnostic Test: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence
Own body perception in relation to functional and structural connection
Measured: Baseline Visit 2 pre hormone treatment
Morphometric differences by sex, gender identity and sexual orientation
Cortical thickness, surface area, cortical and subcortical structural volumes and white matter tracts measured by MRI in relation to sex and gender identity and sexual orientation.
Measured: Baseline Visit 2 pre hormone treatment
Brain activation during own body perception
Images of body morph test presented during fMRI scan
Measured: Baseline Visit 2 pre hormone treatment
Change in cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence
Own body perception in relation to functional and structural connection
Measured: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Change in morphometric differences by sex, gender identity and sexual orientation
Cortical thickness, surface area, cortical and subcortical structural volumes and white matter tracts measured by MRI in relation to sex and gender identity and sexual orientation.
Measured: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Change in brain activation during own body perception
Images of body morph test presented during fMRI scan
Measured: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start22 Feb 2018
- Primary completion1 Feb 2021
- Study completion31 Dec 2021
Why it stopped: The funding agency, the NICHD, did not make a non-competing continuation award for the fifth and final year of the project and moved the grant into closeout.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Feusner, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374708
- Sponsor's protocol ID
- 1R01HD087712-01A1
- Status last verified
- Mar 2023
- First submitted
- 19 Apr 2020
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Identity and Own Body Perception- Implications for the Neurobiology of Gender Dysphoria
- ClinicalTrials.gov ID
- NCT04374708
- Acronym / sponsor ID
- 1R01HD087712-01A1
- Conditions
- Gender Dysphoria
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The funding agency, the NICHD, did not make a non-competing continuation award for the fifth and final year of the project and moved the grant into closeout.
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 22 Feb 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 May 2020 (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.
This study will provide valuable information on the neurobiological underpinning of gender dysphoria (GD) and the effects of sex hormones, and promises to uncover functional or structural neural patterns that could predict outcome in terms of body image and quality of life after cross-sex hormone treatment.
Detailed description
The purpose of this study is to understand the neurobiology of gender dysphoria (GD) and the interactions between cross hormone treatment, the brain, and the body phenotype. The investigators also aim to identify pre-treatment neurobiological and other factors to help predict body congruence and quality of life outcomes from hormone treatment. There is mounting interest in gender identity issues worldwide, as requests for gender-confirming treatments have increased in the past 3 decades, and alarmingly high suicide rates have recently been reported in those with GD. Despite this, little is known about neurobiological or other etiological factors contributing to GD or gender incongruence. This study will address a core feature of GD that has been little studied in terms of the neurobiology: the incongruence between perception of self and one's own body.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| trans men | – | Diagnostic Test: fMRIfMRI: body morph test and neurocognitive testing |
| trans women | – | Diagnostic Test: fMRIfMRI: body morph test and neurocognitive testing |
| homosexual cisgender men | – | Diagnostic Test: fMRIfMRI: body morph test and neurocognitive testing |
| homosexual cisgender women | – | Diagnostic Test: fMRIfMRI: body morph test and neurocognitive testing |
| cisgender women | – | Diagnostic Test: fMRIfMRI: body morph test and neurocognitive testing |
| cisgender men | – | Diagnostic Test: fMRIfMRI: body morph test and neurocognitive testing |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Investigators will enroll 150 participants between the ages of 18 and 40 (25 trans males; 25 trans females; 25 cis gender females; 25 cis gender males; 25 homosexual males; 25 homosexual females)
Key inclusion criteria (7 listed)
- Females and males from any racial or ethnic background, between the ages of 18 years and 40 years.
- Participants must meet Diagnostic and Statistical Manual-5 criteria for GD (302.85)
- Intelligence quotient (IQ) > 80
- Participants with GD
- Females and males from any racial or ethnic background, between the ages of 18 and 40.
Key exclusion criteria (19 listed)
- Previous or on-going sex hormone medication
- Previous sex reassignment surgery
- Oral contraceptives
- Participants with GD are not be taking any other psychotropic medication. (No participant will be recommended to discontinue or taper medications for the purpose of participating in the study.)
- Irregular menstrual cycles
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 |
|---|---|---|
| fMRIfMRI: body morph test and neurocognitive testing | Diagnostic test | cisgender men, cisgender women, homosexual cisgender men, homosexual cisgender women, trans men, trans women |
Primary outcome
cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence
Time frame: Baseline Visit 2 pre hormone treatment
Own body perception in relation to functional and structural connection
Morphometric differences by sex, gender identity and sexual orientation
Time frame: Baseline Visit 2 pre hormone treatment
Cortical thickness, surface area, cortical and subcortical structural volumes and white matter tracts measured by MRI in relation to sex and gender identity and sexual orientation.
Brain activation during own body perception
Time frame: Baseline Visit 2 pre hormone treatment
Images of body morph test presented during fMRI scan
Change in cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence
Time frame: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Own body perception in relation to functional and structural connection
Change in morphometric differences by sex, gender identity and sexual orientation
Time frame: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Cortical thickness, surface area, cortical and subcortical structural volumes and white matter tracts measured by MRI in relation to sex and gender identity and sexual orientation.
Change in brain activation during own body perception
Time frame: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Images of body morph test presented during fMRI scan
Results and safety
The study was stopped early (reason given: The funding agency, the NICHD, did not make a non-competing continuation award for the fifth and final year of the project and moved the grant into closeout.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Dysphoria, run by University of California, Los Angeles 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 7 inclusion and 19 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: stopped early, as of the sponsor's last update on 22 Mar 2023. 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?
The study was stopped early (reason given: The funding agency, the NICHD, did not make a non-competing continuation award for the fifth and final year of the project and moved the grant into closeout.). Results are not available in the source record.
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?
cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence (time frame: Baseline Visit 2 pre hormone treatment). The study lists 6 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 22 Mar 2023.