Health TrialsbyHealthPanel

China Gender-affirming Hormone Therapy Study

ConditionsTransgenderGender Incongruence
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-40
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Disorders of sex development

Who has fertility demand but have not made fertility preservation

With contradictions of GAHT

Comorbid diseases are not under control

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • GAHT for transgender men

    Drug

    Testosterone undecanoate

  • GAHT for transgender women

    Drug

    Estradiol and antiandrogens (Spironolactone or Cyproterone acetate)

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: transgender men1 intervention
Group B: transgender women1 intervention
Group C: Healthy cisgender people0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months
3

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.

Time frame
12 months
4

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

Time frame
12 months

Secondary outcomes

1

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.

Time frame
Up to 12 months
2

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.

Time frame
12 months
3

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.

Time frame
12 months
4

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

Tsinghua University

Collaborator

Source ClinicalTrials.gov
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