Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorXiamen University
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Hormone Overdose and Misuse
Other interventionThis is an observational study. Hormone Overdose and Misuse is an exposure.
Treatment groups
260 Participants
are divided into 2 treatment groupsGroup A: Hormone Overdose and Misuse Group1 intervention
Group B: Non-Hormone Overdose and Misuse Group0 interventions
Trial outcomes
Primary outcomes
1
Moderate-to-severe adverse events
Any adverse events of Grade 2 or higher in Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE v5.0 grades adverse effects as from grade 1 (asymptomatic or mild) to grade 5 (death).
Time frame
24 months from the baseline assessment2
Moderate-to-severe adverse events
Any adverse events of Grade 2 or higher in Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE v5.0 grades adverse effects as from grade 1 (asymptomatic or mild) to grade 5 (death).
Time frame
60 months from the baseline assessmentSecondary outcomes
1
GAHT attrition
Gender affirming hormone treatment attrition due to moderate-to-severe adverse events \[any adverse events of Grade 2 or higher in Common Terminology Criteria for Adverse Events (CTCAE) version 5.0\].
Time frame
24 months from the baseline assessment2
GAHT attrition
Gender affirming hormone treatment attrition due to moderate-to-severe adverse events \[any adverse events of Grade 2 or higher in Common Terminology Criteria for Adverse Events (CTCAE) version 5.0\].
Time frame
60 months from the baseline assessment3
Gender dysphoria
Gender dysphoria, evaluated using Utrecht Gender Dysphoria Scale - Gender Spectrum (UGDS-GS). UGDS-GS scores range from 18 to 90, and higher scores indicate higher levels of gender dysphoria.
Time frame
24 months from the baseline assessment4
Gender dysphoria
Gender dysphoria, evaluated using Utrecht Gender Dysphoria Scale - Gender Spectrum (UGDS-GS). UGDS-GS scores range from 18 to 90, and higher scores indicate higher levels of gender dysphoria.
Time frame
60 months from the baseline assessmentOther outcomes
1
Moderate-to-severe adverse events
Any adverse events of Grade 2 or higher in Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE v5.0 grades adverse effects as from grade 1 (asymptomatic or mild) to grade 5 (death).
Time frame
1 month from the baseline assessment2
Moderate-to-severe adverse events
Any adverse events of Grade 2 or higher in Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE v5.0 grades adverse effects as from grade 1 (asymptomatic or mild) to grade 5 (death).
Time frame
3 months from the baseline assessment3
Moderate-to-severe adverse events
Any adverse events of Grade 2 or higher in Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE v5.0 grades adverse effects as from grade 1 (asymptomatic or mild) to grade 5 (death).
Time frame
6 months from the baseline assessment4
Moderate-to-severe adverse events
Any adverse events of Grade 2 or higher in Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE v5.0 grades adverse effects as from grade 1 (asymptomatic or mild) to grade 5 (death).
Time frame
12 months from the baseline assessmentSponsors and contacts
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Source ClinicalTrials.gov
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