Transgender MentransmenNCT06482385
Transmasculine Quality of Life and Sexual Function at Pre and Post Gender-affirming Hormonal Therapy
An observational study of Transgender Men, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The goal of this prospective observational study is to evaluate the short-term effect of testosterone therapy on these issues among hormone naïve TM individuals. The main questions that aim to answer are : 1. Comparison quality of life in transgender men at pre and post testosterone therapy 2. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Transgender Men
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 15 Sep 2022to 31 May 2024
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: All hormone-naïve TM aged above 18 years who planned to start testosterone at Gender Health Clinic, King Chulalongkorn Memorial Hospital, Thailand
Who may be able to join
- compatible with Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
- had never used testosterone therapy before the enrollment
Who cannot join
- history of abnormal hormone functions
- ongoing treatment or current use of medications that affect hormone functions
- diagnosis of psychiatric illnesses beyond gender dysphoria by a psychiatrist
- prescription of psychiatric or neurological medications within the past 3 months up to the present study participation
- presence of chronic illnesses or severe age-related conditions, such as chronic kidney disease, chronic liver disease, or any type of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Short-term Effects of Testosterone on Quality of Life and Sexual Function Among Hormone-naive Transmasculine in Thailand
The goal of this prospective observational study is to evaluate the short-term effect of testosterone therapy on these issues among hormone naïve TM individuals.
The main questions that aim to answer are :
- Comparison quality of life in transgender men at pre and post testosterone therapy
- To evaluate the most affected domain of quality of life (QOL) and FSFI of this participants
Participants will be ask to complete two questionnaires: the World Health Organization Quality of Life BREF THAI (WHO-QOL-BREF-THAI) and the FSFI (female sexual function index) before testosterone administration and both questionnaires will be re-evaluated at 12 weeks after initiation of testosterone therapy
Read the detailed description
This study was designed as a single-center, prospective trial at King Chulalongkorn Memorial Hospital, Bangkok, Thailand between September 2022 to February 2024.
All hormone-naïve TM aged above 18 years who planned to start testosterone at Gender Health Clinic, King Chulalongkorn Memorial Hospital, Thailand were approached. All the enrolled participants will be received information about the study and written consent was obtained from all participants before the start of the study. The demographic data were recorded. Blood samples of serum estradiol, total testosterone and other laboratory investigations will be assessed including complete blood count, liver function test and lipid profiles. Then, the WHOQOLBREFTHAI questionnaire and Thai version of Female sexual function index questionnaire (FSFI) will be assessed before testosterone administration. All TM participants will be received 250 mg of testosterone enanthate intramuscularly every 4 weeks for 12 weeks. After 12 weeks of treatment, another laboratory investigations and 2 questionnaires, (WHOQOLBREFTHAI and FSFI) will be assessed again.
- Conditions
- Transgender Men
- Keywords
- Transgender men, Sexual function, Gender-affirming hormone therapy, Testosterone, Quality of life, FSFI
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 |
|---|---|---|
| Transgender men | TM in this study were defined as individuals who were compatible with Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). TM who had never used testosterone therapy before the enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life from WHOQOLBREFTHAI questionnaire in transgender men after testosterone therapy
quality of life reporting from WHOQOLBREFTHAI questionnaire in transgender men after testosterone therapy
Measured: 3 months
Secondary outcomes (2)
To evaluate the most affected domain of WHOQOLBREFTHAI questionnaire of this participants
To evaluate the most affected domain of quality of life (WHOQOLBREFTHAI questionnaire) of this participants
Measured: 3 months
To evaluate the sexual function from Thai version of Female sexual function index questionnaire of this participants
To evaluate the FSFI from Thai version of Female sexual function index questionnaire of this participants
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start15 Sep 2022
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transgender MenStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vichadet Vichuladda, M.D., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482385
- Sponsor's protocol ID
- 37465
- Acronym
- transmen
- Status last verified
- Jan 2024
- First submitted
- 2 Feb 2024
- Last updated
- 1 Jul 2024
- Results posted
- 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 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short-term Effects of Testosterone on Quality of Life and Sexual Function Among Hormone-naive Transmasculine in Thailand
- ClinicalTrials.gov ID
- NCT06482385
- Acronym / sponsor ID
- transmen / 37465
- Conditions
- Transgender Men
- Keywords
- Transgender men, Sexual function, Gender-affirming hormone therapy, Testosterone, Quality of life, FSFI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective observational study is to evaluate the short-term effect of testosterone therapy on these issues among hormone naïve TM individuals.
The main questions that aim to answer are :
- Comparison quality of life in transgender men at pre and post testosterone therapy
- To evaluate the most affected domain of quality of life (QOL) and FSFI of this participants
Participants will be ask to complete two questionnaires: the World Health Organization Quality of Life BREF THAI (WHO-QOL-BREF-THAI) and the FSFI (female sexual function index) before testosterone administration and both questionnaires will be re-evaluated at 12 weeks after initiation of testosterone therapy
Detailed description
This study was designed as a single-center, prospective trial at King Chulalongkorn Memorial Hospital, Bangkok, Thailand between September 2022 to February 2024.
All hormone-naïve TM aged above 18 years who planned to start testosterone at Gender Health Clinic, King Chulalongkorn Memorial Hospital, Thailand were approached. All the enrolled participants will be received information about the study and written consent was obtained from all participants before the start of the study. The demographic data were recorded. Blood samples of serum estradiol, total testosterone and other laboratory investigations will be assessed including complete blood count, liver function test and lipid profiles. Then, the WHOQOLBREFTHAI questionnaire and Thai version of Female sexual function index questionnaire (FSFI) will be assessed before testosterone administration. All TM participants will be received 250 mg of testosterone enanthate intramuscularly every 4 weeks for 12 weeks. After 12 weeks of treatment, another laboratory investigations and 2 questionnaires, (WHOQOLBREFTHAI and FSFI) will be assessed again.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transgender men | – | –TM in this study were defined as individuals who were compatible with Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). TM who had never used testosterone therapy before the enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All hormone-naïve TM aged above 18 years who planned to start testosterone at Gender Health Clinic, King Chulalongkorn Memorial Hospital, Thailand
Key inclusion criteria (2 listed)
- compatible with Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
- had never used testosterone therapy before the enrollment
Key exclusion criteria (5 listed)
- history of abnormal hormone functions
- ongoing treatment or current use of medications that affect hormone functions
- diagnosis of psychiatric illnesses beyond gender dysphoria by a psychiatrist
- prescription of psychiatric or neurological medications within the past 3 months up to the present study participation
- presence of chronic illnesses or severe age-related conditions, such as chronic kidney disease, chronic liver disease, or any type of cancer
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
quality of life from WHOQOLBREFTHAI questionnaire in transgender men after testosterone therapy
Time frame: 3 months
quality of life reporting from WHOQOLBREFTHAI questionnaire in transgender men after testosterone therapy
2 secondary outcomes
To evaluate the most affected domain of WHOQOLBREFTHAI questionnaire of this participants
Time frame: 3 months
To evaluate the sexual function from Thai version of Female sexual function index questionnaire of this participants
Time frame: 3 months
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 1 Jul 2024.
- 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.
Vichadet Vichuladda, M.D. principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transgender Men, run by Chulalongkorn University at 1 site in Thailand.
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 2 inclusion and 5 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 1 Jul 2024. 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 Thailand. 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?
quality of life from WHOQOLBREFTHAI questionnaire in transgender men after testosterone therapy (time frame: 3 months). 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 1 Jul 2024.