Actively Recruiting
China Gender-affirming Hormone Therapy Study in Transgender Men and Women
Led by Peking University Third Hospital · Updated on 2024-11-07
240
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Peking University Third Hospital
Lead Sponsor
T
Tsinghua University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying transgender people in China who are beginning gender-affirming hormone therapy (GAHT) to better understand the physical and mental effects of this treatment. This research addresses the lack of data about GAHT in the Chinese transgender population, focusing on social, mental, and health impacts. The study includes transgender men and women diagnosed with gender dysphoria and aims to gather important evidence about their experiences and health changes. Participants will receive GAHT following international guidelines, with transgender men receiving testosterone undecanoate and transgender women receiving estradiol combined with antiandrogens such as spironolactone or cyproterone acetate. The study also includes healthy cisgender people for comparison. The hormone treatments are monitored over a 12-month period, with evaluations at baseline and during treatment to measure physical and psychological changes. During the study, participants will complete questionnaires about their life experiences, gender identity, and mental health. Researchers will assess insulin sensitivity, beta-cell function, bone density, depression, anxiety, suicide ideation, gender dysphoria, social exclusion, and brain function at various points. Safety is monitored through tracking any adverse effects, and participants are followed for a full year. The study aims to provide a comprehensive view of GAHT’s effects using detailed health and psychological assessments.
CONDITIONS
Brief Title
China Gender-affirming Hormone Therapy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Transgender men and women
- Diagnosed with gender dysphoria according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition)
- Aged between 18 to 40 years
- Desire to start gender-affirming hormone therapy (GAHT)
- No previous history of gender-affirming interventions
- Able to provide informed consent
- Right-handed (dextromanual)
You will not qualify if you...
- Disorders of sex development
- Desire for fertility but no fertility preservation done
- Contraindications to GAHT
- Uncontrolled comorbid diseases
- Alcohol or drug abuse
- Hormonal and chromosomal disorders
- History of gender-affirming surgery
- Current psychiatric disorders
- History of brain trauma or neurological diseases
- Use of psychotropic medications within two weeks prior (including antipsychotics, antiepileptics, lithium, benzodiazepines, or opioid analgesics)
- Claustrophobia
- Implanted metal or medical devices such as pacemakers or ceramic teeth
- Tattoos or eyebrow tattooing with heavy metal dye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive gender-affirming hormone therapy (GAHT) following international guidelines, with evaluations of mental and physical health at baseline and during treatment.
Regular visits during treatment for health evaluations
Duration - Up to 12 months
Participants are followed up to 12 months to monitor changes in physical and psychological outcomes after starting GAHT.
Follow-up visits up to 12 months
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Research Team
Y
Ye Liu, PhD., M.D.
T
Tianpei Hong, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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