Clinical trial NCT05583058: Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population
Official title: Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population: a Mixed-methods Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gender Incongruence
Gender Dysphoria
Keywords: Transgender Persons
Gender Affirming Hormone Therapy
Gender Dysphoria
Drug Overdose
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: Tongji University
name: Tsinghua University
First posted: 2022-10-17
Enrollment: 260
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will disseminate a questionnaire among online TGNC communities, social medias, under the help of TGNC-related non-government organizations (NGO). Each participant will be asked to share the link to other TGNCs. Only the completers of the questionnaire who agree to be followed up will be eligible for the cohort study. However, if needed, we will also recruit more TGNCs from outside previous participants via social media.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Moderate-to-severe adverse events
timeFrame: 24 months from the baseline assessment
measure: Moderate-to-severe adverse events
timeFrame: 60 months from the baseline assessment
Secondary outcomes:
measure: GAHT attrition
timeFrame: 24 months from the baseline assessment
measure: GAHT attrition
timeFrame: 60 months from the baseline assessment
measure: Gender dysphoria
timeFrame: 24 months from the baseline assessment
measure: Gender dysphoria
timeFrame: 60 months from the baseline assessment
measure: Depression
timeFrame: 12 months from the baseline assessment
measure: Depression
timeFrame: 24 months from the baseline assessment
measure: Depression
timeFrame: 36 months from the baseline assessment
measure: Depression
timeFrame: 60 months from the baseline assessment
measure: Anxiety
timeFrame: 12 months from the baseline assessment
measure: Anxiety
timeFrame: 24 months from the baseline assessment
measure: Anxiety
timeFrame: 36 months from the baseline assessment
measure: Anxiety
timeFrame: 60 months from the baseline assessment
measure: General quality of life
timeFrame: 24 months from the baseline assessment
measure: General quality of life
timeFrame: 60 months from the baseline assessment
measure: Body image
timeFrame: 24 months from the baseline assessment
measure: Body image
timeFrame: 60 months from the baseline assessment
measure: Body-gender congruence
timeFrame: 24 months from the baseline assessment
measure: Body-gender congruence
timeFrame: 60 months from the baseline assessment
measure: Tanner stage
timeFrame: 12 months from the baseline assessment
measure: Tanner stage
timeFrame: 24 months from the baseline assessment
measure: Tanner stage
timeFrame: 36 months from the baseline assessment
measure: Gender identity
timeFrame: 24 months from the baseline assessment
measure: Gender identity
timeFrame: 60 months from the baseline assessment
Other outcomes:
measure: Moderate-to-severe adverse events
timeFrame: 1 month from the baseline assessment
measure: Moderate-to-severe adverse events
timeFrame: 3 months from the baseline assessment
measure: Moderate-to-severe adverse events
timeFrame: 6 months from the baseline assessment
measure: Moderate-to-severe adverse events
timeFrame: 12 months from the baseline assessment
measure: Moderate-to-severe adverse events
timeFrame: 18 months from the baseline assessment
measure: Moderate-to-severe adverse events
timeFrame: 30 months from the baseline assessment
measure: Moderate-to-severe adverse events
timeFrame: 36 months from the baseline assessment
measure: Moderate-to-severe adverse events
timeFrame: 42 months from the baseline assessment
measure: Moderate-to-severe adverse events
timeFrame: 48 months from the baseline assessment
measure: Moderate-to-severe adverse events
timeFrame: 54 months from the baseline assessment
measure: GAHT attrition
timeFrame: 6 months from the baseline assessment
measure: GAHT attrition
timeFrame: 12 months from the baseline assessment
measure: GAHT attrition
timeFrame: 18 months from the baseline assessment
measure: GAHT attrition
timeFrame: 30 months from the baseline assessment
measure: GAHT attrition
timeFrame: 36 months from the baseline assessment
measure: GAHT attrition
timeFrame: 42 months from the baseline assessment
measure: GAHT attrition
timeFrame: 48 months from the baseline assessment
measure: GAHT attrition
timeFrame: 54 months from the baseline assessment
measure: Gender dysphoria
timeFrame: 3 months from the baseline assessment
measure: Gender dysphoria
timeFrame: 6 months from the baseline assessment
measure: Gender dysphoria
timeFrame: 12 months from the baseline assessment
measure: Gender dysphoria
timeFrame: 18 months from the baseline assessment
measure: Gender dysphoria
timeFrame: 30 months from the baseline assessment
measure: Gender dysphoria
timeFrame: 36 months from the baseline assessment
measure: Gender dysphoria
timeFrame: 42 months from the baseline assessment
measure: Gender dysphoria
timeFrame: 48 months from the baseline assessment
measure: Gender dysphoria
timeFrame: 54 months from the baseline assessment
measure: Depression
timeFrame: 1 month from the baseline assessment
measure: Depression
timeFrame: 3 months from the baseline assessment
measure: Depression
timeFrame: 6 months from the baseline assessment
measure: Depression
timeFrame: 18 months from the baseline assessment
measure: Depression
timeFrame: 30 months from the baseline assessment
measure: Depression
timeFrame: 42 months from the baseline assessment
measure: Depression
timeFrame: 48 months from the baseline assessment
measure: Depression
timeFrame: 54 months from the baseline assessment
measure: Anxiety
timeFrame: 1 month from the baseline assessment
measure: Anxiety
timeFrame: 3 months from the baseline assessment
measure: Anxiety
timeFrame: 6 months from the baseline assessment
measure: Anxiety
timeFrame: 18 months from the baseline assessment
measure: Anxiety
timeFrame: 30 months from the baseline assessment
measure: Anxiety
timeFrame: 42 months from the baseline assessment
measure: Anxiety
timeFrame: 48 months from the baseline assessment
measure: Anxiety
timeFrame: 54 months from the baseline assessment
measure: General quality of life
timeFrame: 6 months from the baseline assessment
measure: General quality of life
timeFrame: 12 months from the baseline assessment
measure: General quality of life
timeFrame: 18 months from the baseline assessment
measure: General quality of life
timeFrame: 30 months from the baseline assessment
measure: General quality of life
timeFrame: 36 months from the baseline assessment
measure: General quality of life
timeFrame: 42 months from the baseline assessment
measure: General quality of life
timeFrame: 48 months from the baseline assessment
measure: General quality of life
timeFrame: 54 months from the baseline assessment
measure: Body image
timeFrame: 6 months from the baseline assessment
measure: Body image
timeFrame: 12 months from the baseline assessment
measure: Body image
timeFrame: 18 months from the baseline assessment
measure: Body image
timeFrame: 30 months from the baseline assessment
measure: Body image
timeFrame: 36 months from the baseline assessment
measure: Body image
timeFrame: 42 months from the baseline assessment
measure: Body image
timeFrame: 48 months from the baseline assessment
measure: Body image
timeFrame: 54 months from the baseline assessment
measure: Body-gender congruence
timeFrame: 3 months from the baseline assessment
measure: Body-gender congruence
timeFrame: 6 months from the baseline assessment
measure: Body-gender congruence
timeFrame: 12 months from the baseline assessment
measure: Body-gender congruence
timeFrame: 18 months from the baseline assessment
measure: Body-gender congruence
timeFrame: 30 months from the baseline assessment
measure: Body-gender congruence
timeFrame: 36 months from the baseline assessment
measure: Body-gender congruence
timeFrame: 42 months from the baseline assessment
measure: Body-gender congruence
timeFrame: 48 months from the baseline assessment
measure: Body-gender congruence
timeFrame: 54 months from the baseline assessment
measure: Tanner stage
timeFrame: 3 months from the baseline assessment
measure: Tanner stage
timeFrame: 6 months from the baseline assessment
measure: Tanner stage
timeFrame: 18 months from the baseline assessment
measure: Tanner stage
timeFrame: 30 months from the baseline assessment
measure: Tanner stage
timeFrame: 42 months from the baseline assessment
measure: Tanner stage
timeFrame: 48 months from the baseline assessment
measure: Tanner stage
timeFrame: 54 months from the baseline assessment
measure: Tanner stage
timeFrame: 60 months from the baseline assessment
measure: Gender identity
timeFrame: 3 months from the baseline assessment
measure: Gender identity
timeFrame: 6 months from the baseline assessment
measure: Gender identity
timeFrame: 12 months from the baseline assessment
measure: Gender identity
timeFrame: 18 months from the baseline assessment
measure: Gender identity
timeFrame: 30 months from the baseline assessment
measure: Gender identity
timeFrame: 36 months from the baseline assessment
measure: Gender identity
timeFrame: 42 months from the baseline assessment
measure: Gender identity
timeFrame: 48 months from the baseline assessment
measure: Gender identity
timeFrame: 54 months from the baseline assessment
Locations:
city: Xiamen
country: China
facility: School of Medicine, Xiamen University
state: Fujian
Study officials:
affiliation: School of Medicine, Xiamen University
name: Ben-tuo Zeng
role: PRINCIPAL_INVESTIGATOR
References: