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NCT Number: NCT05583058

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

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.

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Key information

Conditions

Gender Incongruence Chemically-Induced Disorders Drug Misuse Drug Overdose Gender Dysphoria Mental Disorders Prescription Drug Misuse Sexual Dysfunctions, Psychological Substance-Related Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Medicine, Xiamen University

Xiamen, Fujian, 361102, China

Location contact

Ben-tuo Zeng, B.Sc.

PRINCIPAL_INVESTIGATOR

Binbin Chen

CONTACT

[email protected]

+86-(592)2183380

Yang Liu, Ph.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hormone Overdose and Misuse

Other

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

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. GAHT attrition

    Time frame: 24 months from the baseline assessment

    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].

  2. GAHT attrition

    Time frame: 60 months from the baseline assessment

    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].

  3. Gender dysphoria

    Time frame: 24 months from the baseline assessment

    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.

  4. Gender dysphoria

    Time frame: 60 months from the baseline assessment

    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.

  5. Depression

    Time frame: 12 months from the baseline assessment

    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.

  6. Depression

    Time frame: 24 months from the baseline assessment

    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.

  7. Depression

    Time frame: 36 months from the baseline assessment

    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.

  8. Depression

    Time frame: 60 months from the baseline assessment

    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.

  9. Anxiety

    Time frame: 12 months from the baseline assessment

    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.

  10. Anxiety

    Time frame: 24 months from the baseline assessment

    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.

  11. Anxiety

    Time frame: 36 months from the baseline assessment

    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.

  12. Anxiety

    Time frame: 60 months from the baseline assessment

    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.

  13. General quality of life

    Time frame: 24 months from the baseline assessment

    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.

  14. General quality of life

    Time frame: 60 months from the baseline assessment

    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.

  15. Body image

    Time frame: 24 months from the baseline assessment

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

  16. Body image

    Time frame: 60 months from the baseline assessment

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

  17. Body-gender congruence

    Time frame: 24 months from the baseline assessment

    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.

  18. Body-gender congruence

    Time frame: 60 months from the baseline assessment

    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.

  19. Tanner stage

    Time frame: 12 months from the baseline assessment

    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.

  20. Tanner stage

    Time frame: 24 months from the baseline assessment

    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.

  21. Tanner stage

    Time frame: 36 months from the baseline assessment

    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.

  22. Gender identity

    Time frame: 24 months from the baseline assessment

    Gender identity, evaluated using Visual Analogue Scale, ranging from 0% female to 100% female. This score does not indicate any better or worse conditions.

  23. Gender identity

    Time frame: 60 months from the baseline assessment

    Gender identity, evaluated using Visual Analogue Scale, ranging from 0% female to 100% female. This score does not indicate any better or worse conditions.

Other outcomes

  1. Moderate-to-severe adverse events

    Time frame: 1 month 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).

  2. Moderate-to-severe adverse events

    Time frame: 3 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).

  3. Moderate-to-severe adverse events

    Time frame: 6 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).

  4. Moderate-to-severe adverse events

    Time frame: 12 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).

  5. Moderate-to-severe adverse events

    Time frame: 18 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).

  6. Moderate-to-severe adverse events

    Time frame: 30 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).

  7. Moderate-to-severe adverse events

    Time frame: 36 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).

  8. Moderate-to-severe adverse events

    Time frame: 42 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).

  9. Moderate-to-severe adverse events

    Time frame: 48 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).

  10. Moderate-to-severe adverse events

    Time frame: 54 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).

  11. GAHT attrition

    Time frame: 6 months from the baseline assessment

    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].

  12. GAHT attrition

    Time frame: 12 months from the baseline assessment

    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].

  13. GAHT attrition

    Time frame: 18 months from the baseline assessment

    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].

  14. GAHT attrition

    Time frame: 30 months from the baseline assessment

    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].

  15. GAHT attrition

    Time frame: 36 months from the baseline assessment

    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].

  16. GAHT attrition

    Time frame: 42 months from the baseline assessment

    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].

  17. GAHT attrition

    Time frame: 48 months from the baseline assessment

    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].

  18. GAHT attrition

    Time frame: 54 months from the baseline assessment

    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].

  19. Gender dysphoria

    Time frame: 3 months from the baseline assessment

    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.

  20. Gender dysphoria

    Time frame: 6 months from the baseline assessment

    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.

  21. Gender dysphoria

    Time frame: 12 months from the baseline assessment

    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.

  22. Gender dysphoria

    Time frame: 18 months from the baseline assessment

    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.

  23. Gender dysphoria

    Time frame: 30 months from the baseline assessment

    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.

  24. Gender dysphoria

    Time frame: 36 months from the baseline assessment

    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.

  25. Gender dysphoria

    Time frame: 42 months from the baseline assessment

    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.

  26. Gender dysphoria

    Time frame: 48 months from the baseline assessment

    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.

  27. Gender dysphoria

    Time frame: 54 months from the baseline assessment

    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.

  28. Depression

    Time frame: 1 month from the baseline assessment

    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.

  29. Depression

    Time frame: 3 months from the baseline assessment

    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.

  30. Depression

    Time frame: 6 months from the baseline assessment

    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.

  31. Depression

    Time frame: 18 months from the baseline assessment

    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.

  32. Depression

    Time frame: 30 months from the baseline assessment

    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.

  33. Depression

    Time frame: 42 months from the baseline assessment

    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.

  34. Depression

    Time frame: 48 months from the baseline assessment

    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.

  35. Depression

    Time frame: 54 months from the baseline assessment

    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.

  36. Anxiety

    Time frame: 1 month from the baseline assessment

    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.

  37. Anxiety

    Time frame: 3 months from the baseline assessment

    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.

  38. Anxiety

    Time frame: 6 months from the baseline assessment

    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.

  39. Anxiety

    Time frame: 18 months from the baseline assessment

    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.

  40. Anxiety

    Time frame: 30 months from the baseline assessment

    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.

  41. Anxiety

    Time frame: 42 months from the baseline assessment

    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.

  42. Anxiety

    Time frame: 48 months from the baseline assessment

    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.

  43. Anxiety

    Time frame: 54 months from the baseline assessment

    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.

  44. General quality of life

    Time frame: 6 months from the baseline assessment

    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.

  45. General quality of life

    Time frame: 12 months from the baseline assessment

    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.

  46. General quality of life

    Time frame: 18 months from the baseline assessment

    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.

  47. General quality of life

    Time frame: 30 months from the baseline assessment

    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.

  48. General quality of life

    Time frame: 36 months from the baseline assessment

    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.

  49. General quality of life

    Time frame: 42 months from the baseline assessment

    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.

  50. General quality of life

    Time frame: 48 months from the baseline assessment

    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.

  51. General quality of life

    Time frame: 54 months from the baseline assessment

    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.

  52. Body image

    Time frame: 6 months from the baseline assessment

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

  53. Body image

    Time frame: 12 months from the baseline assessment

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

  54. Body image

    Time frame: 18 months from the baseline assessment

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

  55. Body image

    Time frame: 30 months from the baseline assessment

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

  56. Body image

    Time frame: 36 months from the baseline assessment

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

  57. Body image

    Time frame: 42 months from the baseline assessment

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

  58. Body image

    Time frame: 48 months from the baseline assessment

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

  59. Body image

    Time frame: 54 months from the baseline assessment

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

  60. Body-gender congruence

    Time frame: 3 months from the baseline assessment

    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.

  61. Body-gender congruence

    Time frame: 6 months from the baseline assessment

    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.

  62. Body-gender congruence

    Time frame: 12 months from the baseline assessment

    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.

  63. Body-gender congruence

    Time frame: 18 months from the baseline assessment

    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.

  64. Body-gender congruence

    Time frame: 30 months from the baseline assessment

    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.

  65. Body-gender congruence

    Time frame: 36 months from the baseline assessment

    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.

  66. Body-gender congruence

    Time frame: 42 months from the baseline assessment

    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.

  67. Body-gender congruence

    Time frame: 48 months from the baseline assessment

    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.

  68. Body-gender congruence

    Time frame: 54 months from the baseline assessment

    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.

  69. Tanner stage

    Time frame: 3 months from the baseline assessment

    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.

  70. Tanner stage

    Time frame: 6 months from the baseline assessment

    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.

  71. Tanner stage

    Time frame: 18 months from the baseline assessment

    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.

  72. Tanner stage

    Time frame: 30 months from the baseline assessment

    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.

  73. Tanner stage

    Time frame: 42 months from the baseline assessment

    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.

  74. Tanner stage

    Time frame: 48 months from the baseline assessment

    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.

  75. Tanner stage

    Time frame: 54 months from the baseline assessment

    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.

  76. Tanner stage

    Time frame: 60 months from the baseline assessment

    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.

  77. Gender identity

    Time frame: 3 months from the baseline assessment

    Gender identity, evaluated using Visual Analogue Scale, ranging from 0% female to 100% female. This score does not indicate any better or worse conditions.

  78. Gender identity

    Time frame: 6 months from the baseline assessment

    Gender identity, evaluated using Visual Analogue Scale, ranging from 0% female to 100% female. This score does not indicate any better or worse conditions.

  79. Gender identity

    Time frame: 12 months from the baseline assessment

    Gender identity, evaluated using Visual Analogue Scale, ranging from 0% female to 100% female. This score does not indicate any better or worse conditions.

  80. Gender identity

    Time frame: 18 months from the baseline assessment

    Gender identity, evaluated using Visual Analogue Scale, ranging from 0% female to 100% female. This score does not indicate any better or worse conditions.

  81. Gender identity

    Time frame: 30 months from the baseline assessment

    Gender identity, evaluated using Visual Analogue Scale, ranging from 0% female to 100% female. This score does not indicate any better or worse conditions.

  82. Gender identity

    Time frame: 36 months from the baseline assessment

    Gender identity, evaluated using Visual Analogue Scale, ranging from 0% female to 100% female. This score does not indicate any better or worse conditions.

  83. Gender identity

    Time frame: 42 months from the baseline assessment

    Gender identity, evaluated using Visual Analogue Scale, ranging from 0% female to 100% female. This score does not indicate any better or worse conditions.

  84. Gender identity

    Time frame: 48 months from the baseline assessment

    Gender identity, evaluated using Visual Analogue Scale, ranging from 0% female to 100% female. This score does not indicate any better or worse conditions.

  85. Gender identity

    Time frame: 54 months from the baseline assessment

    Gender identity, evaluated using Visual Analogue Scale, ranging from 0% female to 100% female. This score does not indicate any better or worse conditions.

Study contacts

Contact information is provided by the study sponsor or research team.

Ben-tuo Zeng

CONTACT

[email protected]

+86-18990938417

Sponsors and collaborators

Lead sponsor

Xiamen University

Other

Collaborators

  • Tongji University
  • Tsinghua University

Registry information

Official study title

Sex Hormone Overdose and Misuse in Chinese Transgender and Gender Non-conforming Population: a Mixed-methods Study

Acronym: HODMChina

Important dates

Study start
2022
Primary completion
2028
Study completion
2029
First posted
Oct 17, 2022
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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