Gender DysphoriaNCT06022562
Effects of Gender-affirming Hormone Therapy on Transgender People
An observational study of Gender Dysphoria, run by National Taiwan University at 1 site in Taiwan.
Trial summary
This prospective cohort study aims to assess the impact of gender-affirming hormone therapy (GAHT) on transgender individuals' physical, psychological, social, and quality of life aspects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gender Dysphoria
- How many people
- 227 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Jan 2024to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: transgender
Who may be able to join
- transgender
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University, College of Medicine, School of Nursing
Taipei
About this study
Official title: Effects of Gender-affirming Hormone Therapy on the Psychosocial and Quality of Life of Transgender People: A Prospective Cohort Study
This prospective cohort study aims to assess the impact of gender-affirming hormone therapy (GAHT) on transgender individuals' physical, psychological, social, and quality of life aspects. Based on gender minority stress theory, the research recruits 150 individuals each of those starting GAHT and those not yet undergoing it. Data collection involves questionnaires and physiological measurements. Statistical analyses will explore correlations and group differences. Findings can guide transgender individuals considering hormone therapy and enhance care guidelines to improve their overall well-being.
Read the detailed description
The willingness and proportion of transgender persons diagnosed with gender dysphoria to receive gender-affirming hormone therapy (GAHT) is relatively high, so as to conform to their internal gender identity. However, there are limited studies on the prospectively observation of the influences and effectiveness of GAHT on physical, psychological, social and quality of life of transgender people. This study is a cross-sectional research prospective cohort study design, and the research framework is developed based on gender minority stress theory. It is expected to recruit a group of 150 transgender people, including trans male, trans female, and non-binary person, who have just started using GAHT, and a group of 150 who has not yet received GAHT. The data collection time is about 40-50 minutes each time. The questionnaires will be applied to collect basic demographic information, basic hormonal information, body changes, body image, sexual wellbeing, sexual risk, depression, social support, and quality of life. The instruments will be applied to measure participants' physiological parameters, including weight, body fat, and muscle mass, hand grip strength, and blood pressure. In the statistical part, correlation and regression will be used to analyze the degree of correlation between variables, and multivariate analysis of covariance will be used to detect whether there was a significant difference between the variables of the two groups. A well understanding of the experiences and reactions of transgender people receiving hormone therapy can provide a reference for transgender people before deciding to accept hormone therapy, and can be used as an important reference for formulating care guidelines for gender-affirming hormone therapy to improve the care quality for the gender minority population.
- Conditions
- Gender Dysphoria
- Keywords
- depression, gender-affirming hormone therapy
- Medical subject headings
- Gender Dysphoria, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With gender-affirming hormone therapy | With gender-affirming hormone therapy | |
| Without gender-affirming hormone therapy | Without gender-affirming hormone therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transgender Congruence Scale
Participants rated this 15 items scale on a 5-point Likert-type scale (i.e., 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree nor disagree, 4 = somewhat agree, 5 = strongly agree). Four of the 15 items were designed to be reverse-scored. Item responses were averaged, with higher scores indicating a higher level of congruence. So the maximum and minimum values of this scale are 75 and 15.
Measured: 1 year
Gender Affirming Hormone Treatment Physical Symptoms Assessment Scale
Participants rated this 17 items scale on a 4-point Likert-type scale. With higher scores indicates a higher level.
Measured: 1 year
Sexual Risk Survey (SRS) Items
Participants rated this 23 items. This questionnaire inquires about the frequency of subjects' experiences with each sexual risk. A higher frequency indicates a greater level of risk.
Measured: 1 year
Short Sexual Well Being Scale
Participants rated this 5 items scale on a 7-point Likert-type scale. With higher scores indicates a higher level.
Measured: 1 year
Transgender individual Quality of Life
Participants rated this 23 items scale on a 4-point Likert-type scale. With higher scores indicates a higher level.
Measured: 1 year
Beck Depression Inventory-II
The BDI-II, or Beck Depression Inventory-II, is a widely used self-report assessment tool for measuring the severity of depression. It consists of 21 multiple-choice questions or items. Of these 21 items, 13 are scored in the direction of increasing depression severity, while the remaining 8 are reverse-scored to assess positive attributes.
The possible score range on the BDI-II is from 0 to 63, with higher scores indicating more severe depressive symptoms.
Measured: 1 year
Multidimensional Perceived Social Support Scale
The Multidimensional Perceived Social Support Scale (MPSSS) is a self-report questionnaire designed to assess an individual's perception of the level of social support they receive. It measures support from various sources, such as family, friends, and significant others, and evaluates different dimensions of support, including emotional, instrumental, and informational support. Participants rated this 13 items scale on a 4-point Likert-type scale with 4 different social related group. With higher scores indicates a higher level.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start8 Jan 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gender DysphoriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Piao-Yi Chiou, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022562
- Sponsor's protocol ID
- 202302HM008
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gender-affirming Hormone Therapy on the Psychosocial and Quality of Life of Transgender People: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06022562
- Acronym / sponsor ID
- 202302HM008
- Conditions
- Gender Dysphoria
- Keywords
- depression, gender-affirming hormone therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective cohort study aims to assess the impact of gender-affirming hormone therapy (GAHT) on transgender individuals' physical, psychological, social, and quality of life aspects. Based on gender minority stress theory, the research recruits 150 individuals each of those starting GAHT and those not yet undergoing it. Data collection involves questionnaires and physiological measurements. Statistical analyses will explore correlations and group differences. Findings can guide transgender individuals considering hormone therapy and enhance care guidelines to improve their overall well-being.
Detailed description
The willingness and proportion of transgender persons diagnosed with gender dysphoria to receive gender-affirming hormone therapy (GAHT) is relatively high, so as to conform to their internal gender identity. However, there are limited studies on the prospectively observation of the influences and effectiveness of GAHT on physical, psychological, social and quality of life of transgender people. This study is a cross-sectional research prospective cohort study design, and the research framework is developed based on gender minority stress theory. It is expected to recruit a group of 150 transgender people, including trans male, trans female, and non-binary person, who have just started using GAHT, and a group of 150 who has not yet received GAHT. The data collection time is about 40-50 minutes each time. The questionnaires will be applied to collect basic demographic information, basic hormonal information, body changes, body image, sexual wellbeing, sexual risk, depression, social support, and quality of life. The instruments will be applied to measure participants' physiological parameters, including weight, body fat, and muscle mass, hand grip strength, and blood pressure. In the statistical part, correlation and regression will be used to analyze the degree of correlation between variables, and multivariate analysis of covariance will be used to detect whether there was a significant difference between the variables of the two groups. A well understanding of the experiences and reactions of transgender people receiving hormone therapy can provide a reference for transgender people before deciding to accept hormone therapy, and can be used as an important reference for formulating care guidelines for gender-affirming hormone therapy to improve the care quality for the gender minority population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With gender-affirming hormone therapy | – | –With gender-affirming hormone therapy |
| Without gender-affirming hormone therapy | – | –Without gender-affirming hormone therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- transgender
Key inclusion criteria (1 listed)
- transgender
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transgender Congruence Scale
Time frame: 1 year
Participants rated this 15 items scale on a 5-point Likert-type scale (i.e., 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree nor disagree, 4 = somewhat agree, 5 = strongly agree). Four of the 15 items were designed to be reverse-scored. Item responses were averaged, with higher scores indicating a higher level of congruence. So the maximum and minimum values of this scale are 75 and 15.
Gender Affirming Hormone Treatment Physical Symptoms Assessment Scale
Time frame: 1 year
Participants rated this 17 items scale on a 4-point Likert-type scale. With higher scores indicates a higher level.
Sexual Risk Survey (SRS) Items
Time frame: 1 year
Participants rated this 23 items. This questionnaire inquires about the frequency of subjects' experiences with each sexual risk. A higher frequency indicates a greater level of risk.
Short Sexual Well Being Scale
Time frame: 1 year
Participants rated this 5 items scale on a 7-point Likert-type scale. With higher scores indicates a higher level.
Transgender individual Quality of Life
Time frame: 1 year
Participants rated this 23 items scale on a 4-point Likert-type scale. With higher scores indicates a higher level.
Beck Depression Inventory-II
Time frame: 1 year
The BDI-II, or Beck Depression Inventory-II, is a widely used self-report assessment tool for measuring the severity of depression. It consists of 21 multiple-choice questions or items. Of these 21 items, 13 are scored in the direction of increasing depression severity, while the remaining 8 are reverse-scored to assess positive attributes. The possible score range on the BDI-II is from 0 to 63, with higher scores indicating more severe depressive symptoms.
Multidimensional Perceived Social Support Scale
Time frame: 1 year
The Multidimensional Perceived Social Support Scale (MPSSS) is a self-report questionnaire designed to assess an individual's perception of the level of social support they receive. It measures support from various sources, such as family, friends, and significant others, and evaluates different dimensions of support, including emotional, instrumental, and informational support. Participants rated this 13 items scale on a 4-point Likert-type scale with 4 different social related group. With higher scores indicates a higher level.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender Dysphoria, run by National Taiwan University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transgender Congruence Scale (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.