Actively Recruiting

Age: 18Years - 40Years
All Genders
Healthy Volunteers
ID05318755

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

Age: 18Years - 40Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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)
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Loading map...

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

Similar Trials

Cardiovascular Health of Transgender Individuals During the ...

Gender Incongruence

Actively Recruiting

1 location

Cervical and Endometrial Cancer Screening in Patients Seekin...

Cancer Screening

Actively Recruiting

1 location

Gender Incongruence in Danish Youth (GenDa): An Observationa...

Gender Incongruence

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here