China Gender-affirming Hormone Therapy Study

Transgender Clinical Trial

— CGAHT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05318755
• Other study ID #: CGAHT
• Status: Recruiting
• Start date: April 16, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: Peking University Third Hospital
• Contact: Ye Liu, PhD., M.D.
• Phone: +86-10-82265025
• Email: yeliumed[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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) .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gender Dysphoria
• Gender Incongruence
• Transgender

Intervention

Drug:
• GAHT for transgender men
Testosterone undecanoate
• GAHT for transgender women
Estradiol and antiandrogens (Spironolactone or Cyproterone acetate)

Locations

Country	Name	City	State
China	Peking University Third Hospital	Peking	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Tsinghua University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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/v[(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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from Baseline Homeostatic Model Assessment of Beta-cell function (HOMA-ß) at 12 months	HOMA-ß is calculated as [20 × (fasting insulin [µU/mL]) × (fasting glucose -3·5 [mmol/L])]. HOMA-ß will be evaluated at baseline and every 6 months until 12 months of GAHT.	12 months
Secondary	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
Secondary	Comparison of Transgender and Cisgender Functional Brain Patterns	Functional connectivity will be compared at baseline to understand the brain patterns of transgender.	At baseline
Secondary	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