Clinical trial NCT05318755: China Gender-affirming Hormone Therapy Study
Official title: China Gender-affirming Hormone Therapy Study in Transgender Men and Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transgender
Gender Incongruence
Keywords: Transgender Persons
Gender-affirming Hormone Therapy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Tsinghua University
First posted: 2022-04-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 transgender men, 100 trangender women, 20 healthy cisgender men and 20 healthy cisgender women

Brief summary: Data about transgender medical care, especially the gender-affirming hormone therapy (GAHT) is extremely insufficient in China. Few evidence exists in the physical and psychological effects of the hormonal treatment in Chinese transgender population. CGAHT is designed to describe the social and mental condition of transgender people who are seeking for formal GAHT, and to investigate the physical and psychological effects of GAHT on this population in China.

Detailed description: CGAHT will be conducted in one of the main transgender medical centers in Chinese mainland. Participants who are seeking for the start of GAHT will be enrolled from clinical visitors. Before GAHT, participants will be interviewed with questionaries about their life experience, gender identity and social economic conditions. Evaluations on mental and physical health will be performed at baseline and during the GAHT. Participants will be followed up to 12 months. GAHT will be given to transgender people according to the protocol recommended by the international guideline (doi: 10.1210/jc.2017-01658) .

Eligibility criteria: Inclusion Criteria:

* Transgender men and women
* Meet criteria of Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) for gender dysphoria
* Aged between 18 to 40 years
* People desire to start the GAHT
* No previous history of gender-affirming interventions
* Having full ability to make informed consent
* Dextromanual

Exclusion Criteria:

* Disorders of sex development
* Who has fertility demand but have not made fertility preservation
* With contradictions of GAHT
* Comorbid diseases are not under control
* Alcohol or drug abuse
* Hormonal and chromosomal disorders
* History of gender affirming surgery
* Current psychiatric disorders
* History of brain trauma or neurological pathologies
* Current use of medications with psychotropic effects within two weeks (antipsychotic or antiepileptic agents, lithium, benzodiazepines or opioid analgesics)
* Claustrophobia
* Implanted metal and medical devices (pacemakers, ceramic teeth, etc.),
* Tattoos or eyebrow tattooing (heavy metal dye)

Primary outcomes:
measure: Change from Baseline Insulin Sensitivity at 12 months
timeFrame: 12 months
measure: Change from Baseline Beta-cell Function at 12 months
timeFrame: 12 months
measure: Change from Baseline Bone Mineral Density at 12 months
timeFrame: 12 months
measure: Depression Changes from Baseline Psychological Questionnaires at 12 months
timeFrame: 12 months
measure: Anxiety Changes from Baseline Psychological Questionnaires at 12 months
timeFrame: 12 months
measure: Suicide Ideation Changes from Baseline Psychological Questionnaires at 12 months
timeFrame: 12 months
measure: Gender Dysphoria Changes from Baseline Psychological Questionnaires at 12 months
timeFrame: 12 months
measure: Social Exclusion Changes from Baseline at 12 months
timeFrame: 12 months
measure: Functional brain Change after 6 months of GAHT
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Up to 12 months
measure: Change from Baseline Body Mass Index at 12 months
timeFrame: 12 months
measure: Change from Baseline Waist-hip Ratio at 12 months
timeFrame: 12 months
measure: Change from Baseline Body Composition at 12 months
timeFrame: 12 months
measure: Change from Baseline Breast Volume of transgender women at 12 months
timeFrame: 12 months
measure: Change from Baseline Homeostatic Model Assessment Index (HOMA-IR) at 12 months
timeFrame: 12 months
measure: Change from Baseline Homeostatic Model Assessment of Beta-cell function (HOMA-β) at 12 months
timeFrame: 12 months
measure: Change from Baseline Serum Uric Acid at 12 months
timeFrame: 12 months
measure: Comparison of Transgender and Cisgender Functional Brain Patterns
timeFrame: At baseline
measure: Comparison of Transgender and Cisgender Cognitive Ability
timeFrame: At baseline
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Department of Endocrinology and Metabolism, Peking University Third Hospital
name: Tianpei Hong, PhD., M.D.
role: PRINCIPAL_INVESTIGATOR
References: