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临床试验/NCT06482385
NCT06482385已完成不适用

The Short-term Effects of Testosterone on Quality of Life and Sexual Function Among Hormone-naive Transmasculine in Thailand

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
quality of life from WHOQOLBREFTHAI questionnaire in transgender men after testosterone therapy

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

quality of life from WHOQOLBREFTHAI questionnaire in transgender men after testosterone therapy

时间窗: 3 months

quality of life reporting from WHOQOLBREFTHAI questionnaire in transgender men after testosterone therapy

次要结局

  • To evaluate the sexual function from Thai version of Female sexual function index questionnaire of this participants(3 months)
  • To evaluate the most affected domain of WHOQOLBREFTHAI questionnaire of this participants(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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