China Gender-affirming Hormone Therapy Study (CGAHT)

Peking University

Status: Enrolling

Conditions: Transgender; Gender Incongruence

Treatments: Drug: GAHT for transgender women; Drug: GAHT for transgender men

Study type: Observational

Funder types: Other

Identifiers

NCT05318755

CGAHT

Details and patient eligibility

About

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.

Full 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) .

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

240 participants in 3 patient groups

transgender men

Description:

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

Treatment:

Drug: GAHT for transgender men

transgender women

Description:

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

Treatment:

Drug: GAHT for transgender women

Healthy cisgender people

Description:

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