TransgenderCGAHTNCT05318755
China Gender-affirming Hormone Therapy Study
An observational study of Transgender and Gender Incongruence, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Transgender, Gender Incongruence
- What is being tested?
- GAHT for transgender men and GAHT for transgender women
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 100 transgender men, 100 trangender women, 20 healthy cisgender men and 20 healthy cisgender women
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Tianpei Hong, Pro., 8601082265025, tpho66@bjmu.edu.cn
Ye Liu, Dr., 8601082265025, yeliumed@bjmu.edu.cn
About this study
Official title: 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.
Read the 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) .
- Conditions
- Transgender, Gender Incongruence
- Being tested
- GAHT for transgender men, GAHT for transgender women
- Keywords
- Transgender Persons, Gender-affirming Hormone Therapy
- Medical subject headings
- Gender Dysphoria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAHT for transgender menDrug
Also called Testosterone
Testosterone undecanoate
GAHT for transgender womenDrug
Also called Feminizing drugs
Estradiol and antiandrogens (Spironolactone or Cyproterone acetate)
| Study group | Role | What they receive |
|---|---|---|
| transgender men | People whose sex assigned at birth is female but whose self-identified gender is male. Receives: Drug: GAHT for transgender men | |
| transgender women | People whose sex assigned at birth is male but whose self-identified gender is female. Receives: Drug: GAHT for transgender women | |
| Healthy cisgender people | People whose sex assigned at birth corresponds with their self-identified gender. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 12 months
Functional brain Change after 6 months of GAHT
Change of functional connectivity will be analyzed to understand at 6 months of GAHT.
Measured: 6 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Comparison of Transgender and Cisgender Functional Brain Patterns
Functional connectivity will be compared at baseline to understand the brain patterns of transgender.
Measured: 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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start16 Apr 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransgenderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tsinghua University
- Responsible party
- Principal investigator, Hong Tianpei, Peking University Third Hospital
- Investigators
- Tianpei Hong, PhD., M.D., Principal investigator, Department of Endocrinology and Metabolism, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318755
- Sponsor's protocol ID
- CGAHT
- Acronym
- CGAHT
- Status last verified
- Oct 2026
- First submitted
- 16 Feb 2022
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Dataset is available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Gender-affirming Hormone Therapy Study in Transgender Men and Women
- ClinicalTrials.gov ID
- NCT05318755
- Acronym / sponsor ID
- CGAHT / CGAHT
- Conditions
- Transgender, Gender Incongruence
- Keywords
- Transgender Persons, Gender-affirming Hormone Therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Tsinghua University
- Study start
- 16 Apr 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| transgender men | – | Drug: GAHT for transgender menPeople whose sex assigned at birth is female but whose self-identified gender is male. |
| transgender women | – | Drug: GAHT for transgender womenPeople whose sex assigned at birth is male but whose self-identified gender is female. |
| Healthy cisgender people | – | –People whose sex assigned at birth corresponds with their self-identified gender. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 100 transgender men, 100 trangender women, 20 healthy cisgender men and 20 healthy cisgender women
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAHT for transgender menAlso: TestosteroneTestosterone undecanoate | Drug | transgender men |
| GAHT for transgender womenAlso: Feminizing drugsEstradiol and antiandrogens (Spironolactone or Cyproterone acetate) | Drug | transgender women |
Primary outcome
Change from Baseline Insulin Sensitivity at 12 months
Time frame: 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.
Change from Baseline Beta-cell Function at 12 months
Time frame: 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.
Change from Baseline Bone Mineral Density at 12 months
Time frame: 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.
Depression Changes from Baseline Psychological Questionnaires at 12 months
Time frame: 12 months
Patient Health Questionnaire will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT
Anxiety Changes from Baseline Psychological Questionnaires at 12 months
Time frame: 12 months
Generalized anxiety disorder scale will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT
Suicide Ideation Changes from Baseline Psychological Questionnaires at 12 months
Time frame: 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
Gender Dysphoria Changes from Baseline Psychological Questionnaires at 12 months
Time frame: 12 months
Utrecht gender dysphoria scale will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT
Social Exclusion Changes from Baseline at 12 months
Time frame: 12 months
Cyberball task will be tested at baseline and every 3 months until 12 months to understand the effects of GAHT.
Functional brain Change after 6 months of GAHT
Time frame: 6 months
Change of functional connectivity will be analyzed to understand at 6 months of GAHT.
10 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: Up to 12 months
Change from Baseline Body Mass Index at 12 months
Time frame: 12 months
Change from Baseline Waist-hip Ratio at 12 months
Time frame: 12 months
Change from Baseline Body Composition at 12 months
Time frame: 12 months
Change from Baseline Breast Volume of transgender women at 12 months
Time frame: 12 months
Change from Baseline Homeostatic Model Assessment Index (HOMA-IR) at 12 months
Time frame: 12 months
Change from Baseline Homeostatic Model Assessment of Beta-cell function (HOMA-β) at 12 months
Time frame: 12 months
Change from Baseline Serum Uric Acid at 12 months
Time frame: 12 months
Comparison of Transgender and Cisgender Functional Brain Patterns
Time frame: At baseline
Comparison of Transgender and Cisgender Cognitive Ability
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided. Dataset is available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tianpei Hong, PhD., M.D. principal investigator
Department of Endocrinology and Metabolism, Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgender and Gender Incongruence, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ye Liu, PhD., M.D. (+86-10-82265025, yeliumed@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Insulin Sensitivity at 12 months (time frame: 12 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.