SUN-501 Short-Term Effects of Testosterone Therapy on Quality of Life in Trans Individuals Seeking Masculinisation: A Prespecified Secondary Analysis of a Randomised Clinical Trial

Abstract B.J. Nolan: None. S. Zwickl: None. J.D. Zajac: None. A.S. Cheung: None. Background: Testosterone treatment is a necessary component of management for some transgender and gender diverse (trans) individuals. Observational studies have demonstrated improvements in quality of life (QoL) following commencement of testosterone but no randomised trial has been performed. We aimed to assess the impact of testosterone therapy compared to no treatment on QoL in trans people seeking masculinisation. We hypothesised that testosterone treatment would improve QoL. Methods: This was a prespecified secondary analysis of a 3-month open-label RCT in 64 trans individuals commencing testosterone. Participants were randomised to immediate testosterone commencement (intervention group) or no treatment (standard care waiting list of 3 months prior to commencement). This design ensured no individual would be waiting longer than standard care. QoL was assessed using EQ-visual analogue scale (EQ-VAS) and EQ-5D-5L at 0 and 3 months. EQ-VAS is a visual analogue scale with values between 100 (best imaginable health) and 0 (worst imaginable health). EQ-5D-5L is a questionnaire measuring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression with values between 0 (a state as bad as being dead) and 1 (full health). ANCOVA was used to compare mean differences between groups. Results: In the overall cohort at baseline, mean (SD) EQ-VAS and EQ-5D-5L utility score were 56.8 (20.6) and 0.72 (0.19), respectively. Fifty-eight (93.5%) reported anxiety/depression. Compared to standard care, in individuals receiving testosterone, there was a clinically significant increase in EQ-VAS over 3 months follow-up (mean difference +11.6 points (4.9, 18.3), p=0.02). The between-group change in EQ-5D-5L utility score did not reach statistical significance (mean difference +0.07 (-0.07, 0.21), p=0.06). Conclusion: This RCT demonstrates impaired QoL at baseline and clinically meaningful improvement in QoL over the first 3 months of testosterone therapy for gender affirmation. This study supports the use of testosterone therapy to improve QoL in trans individuals desiring masculinisation. Sunday, June 2, 2024