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

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 :

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

Study Overview

• Status: Completed
• Conditions: Transgender Men

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10260
      • Chulalongkorn University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	3 months

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Vichadet Vichuladda, M.D., Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: February 2, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Testosterone; Sexual function; FSFI; Transgender men; Gender-affirming hormone therapy
• Other Study ID Numbers: 37465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No