China Gender-affirming Hormone Therapy Study

NCT05318755 | Recruiting DMC

• 1 other identifier: CGAHT
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Transgender; Gender Incongruence

Keywords

Transgender Persons; Gender-affirming Hormone Therapy

Outcome Measures

Primary Outcomes (9)

• Change from Baseline Insulin Sensitivity at 12 months

  Insulin sensitivity will be assessed with composite insulin sensitivity index (ISI), which is calculated as 10 000/√\[(fasting glucose \[mg/dL\]) ×(fasting insulin \[μU/mL\]) × (mean glucose \[mg/dL\]) × (mean insulin \[μU/mL\])\], using 0 min, 60 min, and 120 min values of oral glucose tolerance test (OGTT). Composite ISI will be evaluated at baseline and every 6 months until 12 months of GAHT.

  12 months

• Change from Baseline Beta-cell Function at 12 months

  Beta-cell function will be assessed with oral glucose tolerance test-derived disposition index (DI). First, 60 min insulinogenic index (IGI60) is calculated as (insulin60 min-insulin0 min\[μU/mL\])/(glucose60 min-glucose0 min \[mmol/L\]), using 0 min and 60 min values of OGTT. Then DI is calculated by multiplying IGI60 with composite ISI to reflect beta-cell function adjusting for the insulin sensitivity. DI will be evaluated at baseline and every 6 months until 12 months of GAHT.

  12 months

• Change from Baseline Bone Mineral Density at 12 months

  Bone mineral densities (g/cm\^2) of lumber spine and hip will be evaluated by dual-energy X-ray absorptiometry at baseline and 12 months of GAHT.

  12 months

• Depression Changes from Baseline Psychological Questionnaires at 12 months

  Patient Health Questionnaire will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT

  12 months

• Anxiety Changes from Baseline Psychological Questionnaires at 12 months

  Generalized anxiety disorder scale will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT

  12 months

• Suicide Ideation Changes from Baseline Psychological Questionnaires at 12 months

  Beck scale for suicide ideation will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT

  12 months

• Gender Dysphoria Changes from Baseline Psychological Questionnaires at 12 months

  Utrecht gender dysphoria scale will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT

  12 months

• Social Exclusion Changes from Baseline at 12 months

  Cyberball task will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT.

  12 months

• Functional brain Change after 6 months of GAHT

  Change of functional connectivity will be analyzed to understand at 6 months of GAHT.

  6 months

Secondary Outcomes (10)

• Incidence of Treatment-Emergent Adverse Events

  Up to 12 months

• Change from Baseline Body Mass Index at 12 months

  12 months

• Change from Baseline Waist-hip Ratio at 12 months

  12 months

• Change from Baseline Body Composition at 12 months

  12 months

• Change from Baseline Breast Volume of transgender women at 12 months

  12 months

Study Arms (3)

transgender men

People whose sex assigned at birth is female but whose self-identified gender is male.

Drug: GAHT for transgender men

transgender women

People whose sex assigned at birth is male but whose self-identified gender is female.

Drug: GAHT for transgender women

Healthy cisgender people

People whose sex assigned at birth corresponds with their self-identified gender.

Interventions

GAHT for transgender men DRUG

Testosterone undecanoate

Also known as: Testosterone

transgender men

GAHT for transgender women DRUG

Estradiol and antiandrogens (Spironolactone or Cyproterone acetate)

Also known as: Feminizing drugs

transgender women

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Men and women are based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

100 transgender men, 100 trangender women, 20 healthy cisgender men and 20 healthy cisgender women

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Tsinghua University: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine and stool sample will be taken before and during the course of GAHT.

MeSH Terms

Conditions

Gender Dysphoria

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Tianpei Hong, PhD., M.D.

  Department of Endocrinology and Metabolism, Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ye Liu, PhD., M.D.

CONTACT

+86-10-82265025; yeliumed@bjmu.edu.cn

Tianpei Hong, M.D.

CONTACT

+86-10-82266918; tpho66@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: April 8, 2022
• Study Start: April 16, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

CN (1)