CClinicalTrials.gg
Not yet recruitingNCT05583058HODMChinaUpdated Oct 17, 2022

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

An observational study in Gender Incongruence and Gender Dysphoria, sponsored by Xiamen University. Not yet recruiting at 1 site in China. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-17.

Sponsored by Xiamen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
260
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Gender Incongruence
  • Gender Dysphoria

Keywords

  • Transgender Persons
  • Gender Affirming Hormone Therapy
  • Gender Dysphoria
  • Drug Overdose
03

In context

Drug Overdose

139 studies on the registry are indexed under Drug Overdose; 24 are open to participants now.

This study's planned enrollment of 260 is above the median of 175 across 38 observational studies indexed under Drug Overdose.

Browse Drug Overdose studies →

Lead sponsor

Xiamen University is the lead sponsor of 26 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
260 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • OtherHormone Overdose and Misuse

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

06

What researchers measure

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 assessment

  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).

    Time frame: 60 months from the baseline assessment

Secondary 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 assessment

  2. 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 assessment

  3. 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 assessment

  4. 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 assessment

  5. 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.

    Time frame: 12 months from the baseline assessment

  6. 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.

    Time frame: 24 months from the baseline assessment

  7. 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.

    Time frame: 36 months from the baseline assessment

  8. 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.

    Time frame: 60 months from the baseline assessment

  9. 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.

    Time frame: 12 months from the baseline assessment

  10. 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.

    Time frame: 24 months from the baseline assessment

  11. 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.

    Time frame: 36 months from the baseline assessment

  12. 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.

    Time frame: 60 months from the baseline assessment

  13. 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.

    Time frame: 24 months from the baseline assessment

  14. 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.

    Time frame: 60 months from the baseline assessment

  15. Body image

    Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.

    Time frame: 24 months from the baseline assessment

  16. Body image

    Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.

    Time frame: 60 months from the baseline assessment

  17. 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.

    Time frame: 24 months from the baseline assessment

  18. 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.

    Time frame: 60 months from the baseline assessment

  19. 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.

    Time frame: 12 months from the baseline assessment

  20. 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.

    Time frame: 24 months from the baseline assessment

  21. 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.

    Time frame: 36 months from the baseline assessment

  22. 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.

    Time frame: 24 months from the baseline assessment

  23. 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.

    Time frame: 60 months from the baseline assessment

Other 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 assessment

  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).

    Time frame: 3 months from the baseline assessment

  3. 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 assessment

  4. 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 assessment

  5. 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: 18 months from the baseline assessment

  6. 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: 30 months from the baseline assessment

  7. 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: 36 months from the baseline assessment

  8. 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: 42 months from the baseline assessment

  9. 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: 48 months from the baseline assessment

  10. 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: 54 months from the baseline assessment

  11. 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: 6 months from the baseline assessment

  12. 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: 12 months from the baseline assessment

  13. 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: 18 months from the baseline assessment

  14. 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: 30 months from the baseline assessment

  15. 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: 36 months from the baseline assessment

  16. 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: 42 months from the baseline assessment

  17. 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: 48 months from the baseline assessment

  18. 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: 54 months from the baseline assessment

  19. 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: 3 months from the baseline assessment

  20. 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: 6 months from the baseline assessment

  21. 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: 12 months from the baseline assessment

  22. 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: 18 months from the baseline assessment

  23. 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: 30 months from the baseline assessment

  24. 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: 36 months from the baseline assessment

  25. 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: 42 months from the baseline assessment

  26. 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: 48 months from the baseline assessment

  27. 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: 54 months from the baseline assessment

  28. 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.

    Time frame: 1 month from the baseline assessment

  29. 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.

    Time frame: 3 months from the baseline assessment

  30. 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.

    Time frame: 6 months from the baseline assessment

  31. 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.

    Time frame: 18 months from the baseline assessment

  32. 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.

    Time frame: 30 months from the baseline assessment

  33. 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.

    Time frame: 42 months from the baseline assessment

  34. 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.

    Time frame: 48 months from the baseline assessment

  35. 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.

    Time frame: 54 months from the baseline assessment

  36. 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.

    Time frame: 1 month from the baseline assessment

  37. 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.

    Time frame: 3 months from the baseline assessment

  38. 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.

    Time frame: 6 months from the baseline assessment

  39. 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.

    Time frame: 18 months from the baseline assessment

  40. 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.

    Time frame: 30 months from the baseline assessment

  41. 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.

    Time frame: 42 months from the baseline assessment

  42. 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.

    Time frame: 48 months from the baseline assessment

  43. 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.

    Time frame: 54 months from the baseline assessment

  44. 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.

    Time frame: 6 months from the baseline assessment

  45. 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.

    Time frame: 12 months from the baseline assessment

  46. 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.

    Time frame: 18 months from the baseline assessment

  47. 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.

    Time frame: 30 months from the baseline assessment

  48. 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.

    Time frame: 36 months from the baseline assessment

  49. 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.

    Time frame: 42 months from the baseline assessment

  50. 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.

    Time frame: 48 months from the baseline assessment

  51. 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.

    Time frame: 54 months from the baseline assessment

  52. Body image

    Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.

    Time frame: 6 months from the baseline assessment

  53. Body image

    Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.

    Time frame: 12 months from the baseline assessment

  54. Body image

    Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.

    Time frame: 18 months from the baseline assessment

  55. Body image

    Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.

    Time frame: 30 months from the baseline assessment

  56. Body image

    Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.

    Time frame: 36 months from the baseline assessment

  57. Body image

    Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.

    Time frame: 42 months from the baseline assessment

  58. Body image

    Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.

    Time frame: 48 months from the baseline assessment

  59. Body image

    Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.

    Time frame: 54 months from the baseline assessment

  60. 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.

    Time frame: 3 months from the baseline assessment

  61. 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.

    Time frame: 6 months from the baseline assessment

  62. 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.

    Time frame: 12 months from the baseline assessment

  63. 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.

    Time frame: 18 months from the baseline assessment

  64. 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.

    Time frame: 30 months from the baseline assessment

  65. 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.

    Time frame: 36 months from the baseline assessment

  66. 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.

    Time frame: 42 months from the baseline assessment

  67. 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.

    Time frame: 48 months from the baseline assessment

  68. 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.

    Time frame: 54 months from the baseline assessment

  69. 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.

    Time frame: 3 months from the baseline assessment

  70. 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.

    Time frame: 6 months from the baseline assessment

  71. 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.

    Time frame: 18 months from the baseline assessment

  72. 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.

    Time frame: 30 months from the baseline assessment

  73. 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.

    Time frame: 42 months from the baseline assessment

  74. 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.

    Time frame: 48 months from the baseline assessment

  75. 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.

    Time frame: 54 months from the baseline assessment

  76. 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.

    Time frame: 60 months from the baseline assessment

  77. 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.

    Time frame: 3 months from the baseline assessment

  78. 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.

    Time frame: 6 months from the baseline assessment

  79. 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.

    Time frame: 12 months from the baseline assessment

  80. 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.

    Time frame: 18 months from the baseline assessment

  81. 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.

    Time frame: 30 months from the baseline assessment

  82. 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.

    Time frame: 36 months from the baseline assessment

  83. 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.

    Time frame: 42 months from the baseline assessment

  84. 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.

    Time frame: 48 months from the baseline assessment

  85. 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.

    Time frame: 54 months from the baseline assessment

07

Study locations

1 site
  • School of Medicine, Xiamen University
    Xiamen, Fujian 361102, China
    • Binbin Chen · Contact · xdyxyky@126.com · +86-(592)2183380
    • Ben-tuo Zeng, B.Sc. · Principal investigator
    • Yang Liu, Ph.D. · Principal investigator
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05583058
Lead sponsor
Xiamen University
Collaborators
Tongji University, Tsinghua University
Responsible party
Ben-tuo Zeng (Principal Investigator, Xiamen University) — Principal investigator
First posted
Oct 17, 2022
Start date
Dec 15, 2022 (estimated)
Primary completion
Jun 30, 2028 (estimated)
Completion
Mar 30, 2029 (estimated)
Last update
Oct 17, 2022

Study contacts

Ben-tuo Zeng
Contact
zengbentuoxmu@outlook.com
+86-18990938417
Ben-tuo Zeng
principal investigator · School of Medicine, Xiamen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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