Gender IncongruenceHODMChinaNCT05583058
Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population
An observational study of Gender Incongruence and Gender Dysphoria, run by Xiamen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gender Incongruence, Gender Dysphoria
- What is being tested?
- Hormone Overdose and Misuse
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 30 Mar 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
School of Medicine, Xiamen University
Xiamen, Fujian, 361102
Binbin Chen, +86-(592)2183380, xdyxyky@126.com
Ben-tuo Zeng, B.Sc.
About this study
Official title: Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population: a Mixed-methods Study
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:
Read more
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
- Being tested
- Hormone Overdose and Misuse
- Keywords
- Transgender Persons, Gender Affirming Hormone Therapy, Gender Dysphoria, Drug Overdose
- Medical subject headings
- Gender Dysphoria, Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone Overdose and MisuseOther
This is an observational study. Hormone Overdose and Misuse is an exposure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 60 months from the baseline assessment
Secondary outcomes (23)
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].
Measured: 24 months from the baseline assessment
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].
Measured: 60 months from the baseline assessment
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.
Measured: 24 months from the baseline assessment
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.
Measured: 60 months from the baseline assessment
Depression
Depression, evaluated using Patient Health Questionnaire-9 (PHQ-9) scale. PHQ-9 scores range from 0 to 27, and higher scores indicate higher levels of depression.
Measured: 12 months from the baseline assessment
Depression
Depression, evaluated using Patient Health Questionnaire-9 (PHQ-9) scale. PHQ-9 scores range from 0 to 27, and higher scores indicate higher levels of depression.
Measured: 24 months from the baseline assessment
Depression
Depression, evaluated using Patient Health Questionnaire-9 (PHQ-9) scale. PHQ-9 scores range from 0 to 27, and higher scores indicate higher levels of depression.
Measured: 36 months from the baseline assessment
Depression
Depression, evaluated using Patient Health Questionnaire-9 (PHQ-9) scale. PHQ-9 scores range from 0 to 27, and higher scores indicate higher levels of depression.
Measured: 60 months from the baseline assessment
Anxiety
Anxiety, evaluated using General Anxiety Disorder-7 (GAD-7) scale. GAD-7 scores range from 0 to 27, and higher scores indicate higher levels of anxiety.
Measured: 12 months from the baseline assessment
Anxiety
Anxiety, evaluated using General Anxiety Disorder-7 (GAD-7) scale. GAD-7 scores range from 0 to 27, and higher scores indicate higher levels of anxiety.
Measured: 24 months from the baseline assessment
Anxiety
Anxiety, evaluated using General Anxiety Disorder-7 (GAD-7) scale. GAD-7 scores range from 0 to 27, and higher scores indicate higher levels of anxiety.
Measured: 36 months from the baseline assessment
Anxiety
Anxiety, evaluated using General Anxiety Disorder-7 (GAD-7) scale. GAD-7 scores range from 0 to 27, and higher scores indicate higher levels of anxiety.
Measured: 60 months from the baseline assessment
General quality of life
Quality of life, using 36-Item Short Form Survey (SF-36) scale. SF-36 scores range from 0 to 100, and higher scores indicate better quality of life.
Measured: 24 months from the baseline assessment
General quality of life
Quality of life, using 36-Item Short Form Survey (SF-36) scale. SF-36 scores range from 0 to 100, and higher scores indicate better quality of life.
Measured: 60 months from the baseline assessment
Body image
Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.
Measured: 24 months from the baseline assessment
Body image
Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.
Measured: 60 months from the baseline assessment
Body-gender congruence
Body-gender congruence, evaluated using Transgender Congruence Scale (TCS). TCS scores range from 1 to 5 (or 12 to 60), and higher scores indicate better gender congruence.
Measured: 24 months from the baseline assessment
Body-gender congruence
Body-gender congruence, evaluated using Transgender Congruence Scale (TCS). TCS scores range from 1 to 5 (or 12 to 60), and higher scores indicate better gender congruence.
Measured: 60 months from the baseline assessment
Tanner stage
Tanner stages, evaluated using Visual Analogue Scale and Tanner Stage figures. Tanner stages divide the puberty process into 5 stages (stage 1 to stage 5), and higher stages indicate higher levels of puberty.
Measured: 12 months from the baseline assessment
Tanner stage
Tanner stages, evaluated using Visual Analogue Scale and Tanner Stage figures. Tanner stages divide the puberty process into 5 stages (stage 1 to stage 5), and higher stages indicate higher levels of puberty.
Measured: 24 months from the baseline assessment
Tanner stage
Tanner stages, evaluated using Visual Analogue Scale and Tanner Stage figures. Tanner stages divide the puberty process into 5 stages (stage 1 to stage 5), and higher stages indicate higher levels of puberty.
Measured: 36 months from the baseline assessment
Gender identity
Gender identity, evaluated using Visual Analogue Scale, ranging from 0% female to 100% female. This score does not indicate any better or worse conditions.
Measured: 24 months from the baseline assessment
Gender identity
Gender identity, evaluated using Visual Analogue Scale, ranging from 0% female to 100% female. This score does not indicate any better or worse conditions.
Measured: 60 months from the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start15 Dec 2022 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender IncongruenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Xiamen University
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji University, Tsinghua University
- Responsible party
- Principal investigator, Ben-tuo Zeng, Xiamen University
- Investigators
- Ben-tuo Zeng, Principal investigator, School of Medicine, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583058
- Sponsor's protocol ID
- HODM-TGNC-C-01O
- Acronym
- HODMChina
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population: a Mixed-methods Study
- ClinicalTrials.gov ID
- NCT05583058
- Acronym / sponsor ID
- HODMChina / HODM-TGNC-C-01O
- Conditions
- Gender Incongruence, Gender Dysphoria
- Keywords
- Transgender Persons, Gender Affirming Hormone Therapy, Gender Dysphoria, Drug Overdose
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Xiamen UniversityUniversity, hospital or other
- Collaborators
- Tongji University, Tsinghua University
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hormone Overdose and Misuse Group | – | Other: Hormone Overdose and MisuseTransgender 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. |
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormone Overdose and MisuseThis is an observational study. Hormone Overdose and Misuse is an exposure. | Other | Hormone Overdose and Misuse Group |
Primary outcome
Moderate-to-severe adverse events
Time frame: 24 months from the baseline assessment
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).
Moderate-to-severe adverse events
Time frame: 60 months from the baseline assessment
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).
23 secondary outcomes
GAHT attrition
Time frame: 24 months from the baseline assessment
GAHT attrition
Time frame: 60 months from the baseline assessment
Gender dysphoria
Time frame: 24 months from the baseline assessment
Gender dysphoria
Time frame: 60 months from the baseline assessment
Depression
Time frame: 12 months from the baseline assessment
Depression
Time frame: 24 months from the baseline assessment
Depression
Time frame: 36 months from the baseline assessment
Depression
Time frame: 60 months from the baseline assessment
Anxiety
Time frame: 12 months from the baseline assessment
Anxiety
Time frame: 24 months from the baseline assessment
Anxiety
Time frame: 36 months from the baseline assessment
Anxiety
Time frame: 60 months from the baseline assessment
General quality of life
Time frame: 24 months from the baseline assessment
General quality of life
Time frame: 60 months from the baseline assessment
Body image
Time frame: 24 months from the baseline assessment
Body image
Time frame: 60 months from the baseline assessment
Body-gender congruence
Time frame: 24 months from the baseline assessment
Body-gender congruence
Time frame: 60 months from the baseline assessment
Tanner stage
Time frame: 12 months from the baseline assessment
Tanner stage
Time frame: 24 months from the baseline assessment
Tanner stage
Time frame: 36 months from the baseline assessment
Gender identity
Time frame: 24 months from the baseline assessment
Gender identity
Time frame: 60 months from the baseline assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ben-tuo Zeng principal investigator
School of Medicine, Xiamen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Incongruence and Gender Dysphoria, run by Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ben-tuo Zeng (+86-18990938417, zengbentuoxmu@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate-to-severe adverse events (time frame: 24 months from the baseline assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.