Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population (HODMChina)

Xiamen University

Status: Not yet enrolling

Conditions: Gender Dysphoria; Gender Incongruence

Treatments: Other: Hormone Overdose and Misuse

Study type: Observational

Funder types: Other

Identifiers

NCT05583058

HODM-TGNC-C-01O

Details and patient eligibility

About

The investigators propose to investigate the definition of hormone overdose and misuse (HODM) in Chinese transgender and gender nonconforming population (TGNCs), address the incidence of HODM in Chinese TGNC population, related factors and risks, identify the probable causes of HODM, and follow up HODM individuals to explore long-term effects.

The research questions are:

Q1 What is the definition and the criteria of HODM in Chinese TGNC population? Q2 What is the prevalence of HODM in Chinese TGNC population? Q3 What factors and risks are relevant to HODM? Q4 What are the causes? Q5 What are the long-term effects of HODM in Chinese TGNC population, compared to those who enroll in regular GAHT regimens?

The investigators decide to employ a mixed-methods design to construct a full research framework on HODM. A prospective cohort study is a component of the study.

The study can be divided into four stages to address research questions. Stage I will establish a precise definition and eligibility criteria of HODM through expert panel meeting and stakeholder engagement. Subsequently, a cross-sectional study will be conducted to evaluate the rate, subtypes, and related factors of HODM in Chinese TGNCs. In Stage III, semi-structured interviews and focus groups for TGNCs who are identified as HODM will be employed to investigate the causes, motivations and personal impact factors. This stage will be divided into two phases, Stage III-a before the cross-sectional study to provide a brief picture of HODM behaviors, and Stage III-b after the cross-sectional study to draw an overall pattern. Lastly, all participants of Stage II or III who would like to participate in our follow-up will be included in prospective cohorts to assess long-term effects.

Among the stages, the cohort study is the subject of the registration. The investigators propose two cohorts in the study. Participants who are identified as HODM will be assigned to cohort 1 [HODM cohort], and those who are identified as regular GAHT use will be assigned to cohort 2 [non-HODM cohort]. Participants will be asked to report their gender-related and hormone use-related conditions, and mental health-related conditions at specific timepoints. The investigators will compare the HODM cohort to the non-HODM cohort to see if the overall incidence of adverse effects, gender-related, hormone-related, and mental health-related conditions differ in the cohorts.

Enrollment: 260 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Individuals with Chinese nationality (excluding Hong Kong SAR, Macau SAR, and Taiwan).
• Aged over 12.
• Identify themselves as TGNCs of any subtypes, including transgender female, transgender male, genderqueer, gender non-binary, crossdresser, or other subtypes.
• have experienced at least one month of GAHT of any regimens and frequency in the last one year, or is taking hormones during the period of the study.
• Hormones taken include androgen, estrogen, progesterone, anti-androgen, and anti-estrogen of any chemical structures, trade names, or regimens.

Exclusion criteria

• Individuals who undertake GAHT in the absence of self-consciousness due to mental disorders, or under external coercion/abuse.
• Refuse to sign or unable to understand the informed consent.

Trial design

260 participants in 2 patient groups

Hormone Overdose and Misuse Group

Description:

Transgender and gender non-conforming individuals who have been identified as hormone overdose and misuse (HODM) at start of the cohorts according to the criteria established by the study.

Treatment:

Other: Hormone Overdose and Misuse

Non-Hormone Overdose and Misuse Group

Description:

Transgender and gender non-conforming individuals who have been identified as without hormone overdose or misuse (HODM) at start of the cohorts according to the criteria established by the study.