China Gender-affirming Hormone Therapy Study

NCT ID: NCT05318755

Last Updated: 2024-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-16

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Transgender Gender Incongruence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

transgender men

People whose sex assigned at birth is female but whose self-identified gender is male.

GAHT for transgender men

Intervention Type DRUG

Testosterone undecanoate

transgender women

People whose sex assigned at birth is male but whose self-identified gender is female.

GAHT for transgender women

Intervention Type DRUG

Estradiol and antiandrogens (Spironolactone or Cyproterone acetate)

Healthy cisgender people

People whose sex assigned at birth corresponds with their self-identified gender.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GAHT for transgender men

Testosterone undecanoate

Intervention Type DRUG

GAHT for transgender women

Estradiol and antiandrogens (Spironolactone or Cyproterone acetate)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Testosterone Feminizing drugs

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tsinghua University

OTHER

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hong Tianpei

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tianpei Hong, PhD., M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology and Metabolism, Peking University Third Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ye Liu, PhD., M.D.

Role: CONTACT

+86-10-82265025

Tianpei Hong, M.D.

Role: CONTACT

+86-10-82266918

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tianpei Hong, Pro.

Role: primary

8601082265025

Ye Liu, Dr.

Role: backup

8601082265025

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CGAHT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gender-Affirming Care and Mental Health
NCT07171645 NOT_YET_RECRUITING