Transmasculine Quality of Life and Sexual Function at Pre and Post Gender-affirming Hormonal Therapy

NCT ID: NCT06482385

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-15

Study Completion Date

2024-05-31

Brief Summary

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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. 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

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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

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Transgender Men

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* compatible with Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
* had never used testosterone therapy before the enrollment

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vichadet Vichuladda, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Chulalongkorn University

Pathum Wan, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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37465

Identifier Type: -

Identifier Source: org_study_id

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