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

NCT06482385 | Completed

• 1 other identifier: 37465
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.Comparison quality of life in transgender men at pre and post testosterone therapy
2. 2.To evaluate the most affected domain of quality of life (QOL) and FSFI of this participants

Conditions

Transgender Men

Keywords

Transgender men; Sexual function; Gender-affirming hormone therapy; Testosterone; Quality of life; FSFI

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Secondary Outcomes (2)

• To evaluate the most affected domain of WHOQOLBREFTHAI questionnaire of this participants

  3 months

• To evaluate the sexual function from Thai version of Female sexual function index questionnaire of this participants

  3 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: transgender men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All hormone-naïve TM aged above 18 years who planned to start testosterone at Gender Health Clinic, King Chulalongkorn Memorial Hospital, Thailand

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn University

Pathum Wan, Bangkok, 10260, Thailand

Location

Study Officials

• Vichadet Vichuladda, M.D.

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: July 1, 2024
• Study Start: September 15, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-01

Locations

TH (1)