Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482385
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2024-02-02
Brief Title:
Transmasculine Quality of Life and Sexual Function at Pre and Post Gender-affirming Hormonal Therapy
Sponsor:
Chulalongkorn University
Organization:
Chulalongkorn University
Study Overview
Official Title:
The Short-term Effects of Testosterone on Quality of Life and Sexual Function Among Hormone-naive Transmasculine in Thailand
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
transmen
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 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
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:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None