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

NCT05583058 | Not Yet Recruiting

• 1 other identifier: HODM-TGNC-C-01O
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 1

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.

Conditions

Gender Incongruence; Gender Dysphoria

Keywords

Transgender Persons; Gender Affirming Hormone Therapy; Gender Dysphoria; Drug Overdose

Outcome Measures

Primary Outcomes (2)

• 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).

  24 months from the baseline assessment

• 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).

  60 months from the baseline assessment

Secondary Outcomes (23)

• GAHT attrition

  24 months from the baseline assessment

• GAHT attrition

  60 months from the baseline assessment

• Gender dysphoria

  24 months from the baseline assessment

• Gender dysphoria

  60 months from the baseline assessment

• Depression

  12 months from the baseline assessment

Other Outcomes (85)

• Moderate-to-severe adverse events

  1 month from the baseline assessment

• Moderate-to-severe adverse events

  3 months from the baseline assessment

• Moderate-to-severe adverse events

  6 months from the baseline assessment

Study Arms (2)

Hormone Overdose and Misuse Group

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.

Other: Hormone Overdose and Misuse

Non-Hormone Overdose and Misuse Group

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.

Interventions

Hormone Overdose and Misuse OTHER

This is an observational study. Hormone Overdose and Misuse is an exposure.

Hormone Overdose and Misuse Group

Eligibility Criteria

• Age: 12 Years+
• Gender Eligibility Details: Only individuals who identified themselves as transgender female, transgender male, genderqueer, gender non-binary, crossdresser, or any other subgroups of Transgender and Gender Non-conforming population (TGNCs) will be recruited.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiamen University: lead
• Tongji University: collaborator
• Tsinghua University: collaborator

Study Sites (1)

School of Medicine, Xiamen University

Xiamen, Fujian, 361102, China

Location

Related Links

• Study protocol

MeSH Terms

Conditions

Gender Dysphoria; Drug Overdose

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Ben-tuo Zeng

  School of Medicine, Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ben-tuo Zeng

CONTACT

+86-18990938417; zengbentuoxmu@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 17, 2022
• Study Start: December 15, 2022
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): March 30, 2029
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)