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

Gender Dysphoria Clinical Trial

— HODMChina  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05583058
• Other study ID #: HODM-TGNC-C-01O
• Status: Not yet recruiting
• Start date: December 15, 2022
• Est. completion date: March 30, 2029

Study information

• Verified date: October 2022
• Source: Xiamen University
• Contact: Ben-tuo Zeng
• Phone: +86-18990938417
• Email: zengbentuoxmu[@]outlook.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: March 30, 2029
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Overdose
• Gender Dysphoria
• Gender Incongruence

Intervention

Other:
• Hormone Overdose and Misuse
This is an observational study. Hormone Overdose and Misuse is an exposure.

Locations

Country	Name	City	State
China	School of Medicine, Xiamen University	Xiamen	Fujian

Sponsors (3)

Lead Sponsor	Collaborator
Xiamen University	Tongji University, Tsinghua University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	1 month from the baseline assessment
Other	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).	3 months from the baseline assessment
Other	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).	6 months from the baseline assessment
Other	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).	12 months from the baseline assessment
Other	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).	18 months from the baseline assessment
Other	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).	30 months from the baseline assessment
Other	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).	36 months from the baseline assessment
Other	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).	42 months from the baseline assessment
Other	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).	48 months from the baseline assessment
Other	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).	54 months from the baseline assessment
Other	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].	6 months from the baseline assessment
Other	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].	12 months from the baseline assessment
Other	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].	18 months from the baseline assessment
Other	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].	30 months from the baseline assessment
Other	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].	36 months from the baseline assessment
Other	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].	42 months from the baseline assessment
Other	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].	48 months from the baseline assessment
Other	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].	54 months from the baseline assessment
Other	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.	3 months from the baseline assessment
Other	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.	6 months from the baseline assessment
Other	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.	12 months from the baseline assessment
Other	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.	18 months from the baseline assessment
Other	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.	30 months from the baseline assessment
Other	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.	36 months from the baseline assessment
Other	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.	42 months from the baseline assessment
Other	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.	48 months from the baseline assessment
Other	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.	54 months from the baseline assessment
Other	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.	1 month from the baseline assessment
Other	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.	3 months from the baseline assessment
Other	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.	6 months from the baseline assessment
Other	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.	18 months from the baseline assessment
Other	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.	30 months from the baseline assessment
Other	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.	42 months from the baseline assessment
Other	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.	48 months from the baseline assessment
Other	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.	54 months from the baseline assessment
Other	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.	1 month from the baseline assessment
Other	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.	3 months from the baseline assessment
Other	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.	6 months from the baseline assessment
Other	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.	18 months from the baseline assessment
Other	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.	30 months from the baseline assessment
Other	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.	42 months from the baseline assessment
Other	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.	48 months from the baseline assessment
Other	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.	54 months from the baseline assessment
Other	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.	6 months from the baseline assessment
Other	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.	12 months from the baseline assessment
Other	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.	18 months from the baseline assessment
Other	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.	30 months from the baseline assessment
Other	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.	36 months from the baseline assessment
Other	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.	42 months from the baseline assessment
Other	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.	48 months from the baseline assessment
Other	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.	54 months from the baseline assessment
Other	Body image	Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.	6 months from the baseline assessment
Other	Body image	Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.	12 months from the baseline assessment
Other	Body image	Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.	18 months from the baseline assessment
Other	Body image	Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.	30 months from the baseline assessment
Other	Body image	Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.	36 months from the baseline assessment
Other	Body image	Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.	42 months from the baseline assessment
Other	Body image	Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.	48 months from the baseline assessment
Other	Body image	Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.	54 months from the baseline assessment
Other	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.	3 months from the baseline assessment
Other	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.	6 months from the baseline assessment
Other	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.	12 months from the baseline assessment
Other	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.	18 months from the baseline assessment
Other	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.	30 months from the baseline assessment
Other	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.	36 months from the baseline assessment
Other	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.	42 months from the baseline assessment
Other	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.	48 months from the baseline assessment
Other	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.	54 months from the baseline assessment
Other	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.	3 months from the baseline assessment
Other	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.	6 months from the baseline assessment
Other	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.	18 months from the baseline assessment
Other	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.	30 months from the baseline assessment
Other	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.	42 months from the baseline assessment
Other	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.	48 months from the baseline assessment
Other	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.	54 months from the baseline assessment
Other	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.	60 months from the baseline assessment
Other	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.	3 months from the baseline assessment
Other	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.	6 months from the baseline assessment
Other	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.	12 months from the baseline assessment
Other	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.	18 months from the baseline assessment
Other	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.	30 months from the baseline assessment
Other	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.	36 months from the baseline assessment
Other	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.	42 months from the baseline assessment
Other	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.	48 months from the baseline assessment
Other	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.	54 months from the baseline assessment
Primary	Moderate-to-severe adverse events	Any adverse events of Grade 2 or higher in Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE v5.0 grades adverse effects as from grade 1 (asymptomatic or mild) to grade 5 (death).	24 months from the baseline assessment
Primary	Moderate-to-severe adverse events	Any adverse events of Grade 2 or higher in Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. CTCAE v5.0 grades adverse effects as from grade 1 (asymptomatic or mild) to grade 5 (death).	60 months from the baseline assessment
Secondary	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].	24 months from the baseline assessment
Secondary	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].	60 months from the baseline assessment
Secondary	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.	24 months from the baseline assessment
Secondary	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.	60 months from the baseline assessment
Secondary	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.	12 months from the baseline assessment
Secondary	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.	24 months from the baseline assessment
Secondary	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.	36 months from the baseline assessment
Secondary	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.	60 months from the baseline assessment
Secondary	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.	12 months from the baseline assessment
Secondary	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.	24 months from the baseline assessment
Secondary	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.	36 months from the baseline assessment
Secondary	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.	60 months from the baseline assessment
Secondary	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.	24 months from the baseline assessment
Secondary	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.	60 months from the baseline assessment
Secondary	Body image	Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.	24 months from the baseline assessment
Secondary	Body image	Body image, using Body Image States Scale (BISS). BISS scores range from 6 to 54, and higher scores indicate worse body images.	60 months from the baseline assessment
Secondary	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.	24 months from the baseline assessment
Secondary	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.	60 months from the baseline assessment
Secondary	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.	12 months from the baseline assessment
Secondary	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.	24 months from the baseline assessment
Secondary	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.	36 months from the baseline assessment
Secondary	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.	24 months from the baseline assessment
Secondary	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.	60 months from the baseline assessment

External Links

•   Study protocol