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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04374708
Other study ID # 1R01HD087712-01A1
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date February 22, 2018
Est. completion date December 31, 2021

Study information

Verified date March 2023
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 132
Est. completion date December 31, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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. 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
fMRI
fMRI: body morph test and neurocognitive testing

Locations

Country Name City State
United States UCLA Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Baseline Visit 2 pre hormone treatment
Primary 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. Baseline Visit 2 pre hormone treatment
Primary Brain activation during own body perception Images of body morph test presented during fMRI scan Baseline Visit 2 pre hormone treatment
Primary 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 Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Primary 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. Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
Primary Change in brain activation during own body perception Images of body morph test presented during fMRI scan Post hormone treatment. Visit 4 last appt. within 2 yrs of Visit 2.
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