TerminatedNot Applicable

Gender Identity and Own Body Perception

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.

United States132 participantsStarted 2018-02-22

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Participants with gender dysphoria (GD) Inclusion Criteria: * 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 Exclusion Criteria: * 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 Inclusion Criteria: * Females and males from any racial or ethnic background, between the ages of 18 and 40. * IQ \> 80 Control participants Exclusion Criteria: * 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 Exclusion criteria for all participants: * 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. Th…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence

Timeframe: Baseline Visit 2 pre hormone treatment

Morphometric differences by sex, gender identity and sexual orientation

Timeframe: Baseline Visit 2 pre hormone treatment

Brain activation during own body perception

Timeframe: 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

Timeframe: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.

Change in morphometric differences by sex, gender identity and sexual orientation

Timeframe: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.

Change in brain activation during own body perception

Timeframe: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.

Trial details

NCT IDNCT04374708

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-02-01

View on ClinicalTrials.gov More Gender Dysphoria trials

Plain-language summary

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

cerebral networks measured by functional magnetic resonance imaging (fMRI) mediating body perception and association with subjective own-body self-incongruence

Timeframe: Baseline Visit 2 pre hormone treatment

Morphometric differences by sex, gender identity and sexual orientation

Timeframe: Baseline Visit 2 pre hormone treatment

Brain activation during own body perception

Timeframe: 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

Timeframe: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.

Change in morphometric differences by sex, gender identity and sexual orientation

Timeframe: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.

Change in brain activation during own body perception

Timeframe: Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.