SAT-151 Real-World Effects of Testosterone Replacement Therapy on Hematocrit and Patient-Reported Outcome Measures: A Retrospective, Longitudinal Cohort Study

Abstract Disclosure: A.K. Clift: I am an employee of Manual (Menwell Ltd), a healthcare provider that provides testosterone replacement therapy. D.R. Huang: I am an employee of Manual (Menwell Ltd), a healthcare provider that provides testosterone replacement therapy. M. Khera: Consulting fees from Endo, Inc., serves as a consultant for Halozyme, Marius Pharmaceuticals, Petros Pharma, AbbVie, Inc., Tolmar, and Boston Scientific, and holds stocks of Sprout Pharmaceuticals. Existing randomised trials of testosterone replacement therapy (TRT) for adult men with testosterone deficiency (TD) used topical testosterone. In real-world practice, clinicians also utilise injectable forms of TRT, and/or agents such as clomiphene. The effects of these agents over time on safety (i.e. raised hematocrit [Hct]) and patient-reported quality of life measures in real-world practice are not well characterized. We performed a retrospective service evaluation (cohort study) of men treated for TD at private healthcare providers in the UK between Feb 2019 and Oct 2024. Baseline and follow-up values for QADAM quality of life scores and Hct levels were extracted, with up to 12 months of follow-up. Mixed effects approaches were used to model trends in QADAM and Kaplan-Meier methods used to calculate the incidence of high Hct (>0.54). Patients may be treated on the basis of biochemical and symptomatic profiles at individual experts’ discretion: secondary analyses stratified by level of baseline T (Group 1 = free T<0.226 or total T<12.2; Group 2 = free T 0.226-0.3, but total T>14.9; Group 3 = total T 12-15 but free T in reference range, Group 4 = prevalent TRT users transferred from other providers). Of a total of 6,376 men, 4,414 were in Group 1 (69.23%), 105 were in Group 2 (1.65%), 1,455 were in Group 3 (22.82%), and 402 were in Group 4 (6.30%). 210 (3.29%) were prescribed testosterone creams or gels, 216 (3.39%) were prescribed clomiphene, 5,043 (79.09%) were prescribed cypionate, 1,046 (16.41%) were prescribed enanthate and 545 (8.55%) were prescribed Sustanon during the course of their treatment (some men switched treatments). The average QADAM score at baseline was 27.14 (95% CI: 26.98 to 27.30), at 12months this was 43.58 (95% CI: 43.11 to 44.06). Absolute increases in QADAM scores at 12months ranged between +10.46 to +11.71 by sub-group, with overlapping CIs across groups. 328 men (3.24%) had follow-up Hct> 0.54 (range: 0.99% in Group 2 to 3.34% in Group 4). No significant difference was observed between groups for the incidence of Hct>0.54 (log rank test, p=0.31). The use of TRT was associated with statistically and clinically significant increases in QADAM scores, a patient-reported measure of quality of life in men with TD. The incidence of Hct>0.54 was rare, with no significant difference across baseline T-defined sub-groups. The incidence of cardiovascular events in different sub-groups of men undergoing TRT should be prospectively studied. Presentation: Saturday, July 12, 2025