China Gender-affirming Hormone Therapy Study (CGAHT)

China Gender-affirming Hormone Therapy Study in Transgender Men and Women

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.

Study Overview

• Status: Recruiting
• Conditions: Transgender; Gender Incongruence
• Intervention / Treatment: Drug: GAHT for transgender men; Drug: GAHT for transgender women

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) .

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Ye Liu, PhD., M.D.; Phone Number: +86-10-82265025; Email: yeliumed@bjmu.edu.cn
• Study Contact Backup: Name: Tianpei Hong, M.D.; Phone Number: +86-10-82266918; Email: tpho66@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Peking, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Tianpei Hong, Pro.; Phone Number: 8601082265025; Email: tpho66@bjmu.edu.cn
      • Contact: Ye Liu, Dr.; Phone Number: 8601082265025; Email: yeliumed@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
transgender men; People whose sex assigned at birth is female but whose self-identified gender is male.	Drug: GAHT for transgender men; Testosterone undecanoate; Other Names: Testosterone
transgender women; People whose sex assigned at birth is male but whose self-identified gender is female.	Drug: GAHT for transgender women; Estradiol and antiandrogens (Spironolactone or Cyproterone acetate); Other Names: Feminizing drugs
Healthy cisgender people; People whose sex assigned at birth corresponds with their self-identified gender.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	The incidence of adverse events during the 12 months of GAHT will be calculated, including thromboembolic events, drug-induced liver injury, hyperkalemia, newly diagnosed cardiovascular disease, erythrocytosis and newly diagnosed tumor.	Up to 12 months
Change from Baseline Body Mass Index at 12 months	Body mass index is calculated as [weight (kg) / height (m)^2], which will be evaluated at baseline and every 3 months until 12 months of GAHT.	12 months
Change from Baseline Waist-hip Ratio at 12 months	Waist-hip ratio is calculated as [waist (cm)/hip (cm)], which will be evaluated at baseline and every 3 months until 12 months of GAHT.	12 months
Change from Baseline Body Composition at 12 months	Fat percentage (%) and lean mass (kg) will be assessed using the InBody S10. The body composition will be evaluated at baseline and 12 months of GAHT.	12 months
Change from Baseline Breast Volume of transgender women at 12 months	Breasts of transgender women will be shot in 360° with 3D photography. The volume (ml) of both sides will be measured by the image analysis at baseline and every 6 months until 12 months of GAHT.	12 months
Change from Baseline Homeostatic Model Assessment Index (HOMA-IR) at 12 months	HOMA-IR is calculated as [(fasting insulin [µU/mL] × fasting glucose [mmol/L])/22.5]. HOMA-IR will be evaluated at baseline and every 6 months until 12 months of GAHT.	12 months
Change from Baseline Homeostatic Model Assessment of Beta-cell function (HOMA-β) at 12 months	HOMA-β is calculated as [20 × (fasting insulin [μU/mL]) × (fasting glucose -3·5 [mmol/L])]. HOMA-β will be evaluated at baseline and every 6 months until 12 months of GAHT.	12 months
Change from Baseline Serum Uric Acid at 12 months	Serum Uric Acid levels (μmol/l) will be evaluated at baseline and every 3 months until 12 months of GAHT.	12 months
Comparison of Transgender and Cisgender Functional Brain Patterns	Functional connectivity will be compared at baseline to understand the brain patterns of transgender.	At baseline
Comparison of Transgender and Cisgender Cognitive Ability	Performance of mental rotation task of transgender and cisgender will be compared at baseline to understand the difference.	At baseline

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Tsinghua University
• Investigators: Principal Investigator: Tianpei Hong, PhD., M.D., Department of Endocrinology and Metabolism, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Estimated): November 7, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Transgender Persons; Gender-affirming Hormone Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Gender Dysphoria; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: CGAHT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Dataset is available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No