(200) Real-World Effectiveness and Safety of Treatment for Testosterone Deficiency: A Cohort Study of Men Stratified by Baseline Testosterone Profiles
Abstract
Randomized controlled trials of treatments for testosterone deficiency (TD) predominantly involved transdermal or intramuscular injectable forms of testosterone (T). In contemporary clinical practice, treatment strategies vary and may incorporate adjunct therapies. Further, biochemical thresholds for diagnosis vary, such as those reported by the British Society for Sexual Medicine (BSSM) and the American Urological Association.
To characterize the real-world effectiveness and safety of treatment for TD over 12 months, and compare these across groups of men categorised on their baseline T levels.
We conducted a retrospective service evaluation (cohort) study of symptomatic adult males treated for TD by a large, national coverage healthcare provider in the United Kingdom. Mixed effects models characterized trends in total T, free T, hematocrit (Hct) and 8 quality of life (QoL) domains from baseline to 12 months follow-up. Kaplan-Meier methods were used to estimate the incidence of Hct>0.54 during treatment. Men were categorised into 4 groups: Group 1 (total T 15nmol/L and free T>0.3nmol/L, who had transferred from other providers).
The cohort comprised 9,537 men with a median age of 42 years. There were 6,035 men in Group 1; 177 in Group 2; 2,551 in Group 3; and 774 in Group 4. 8,517 were prescribed sub-cutaneous testosterone (89.20%); 366 were prescribed transdermal testosterone (3.84%); 7,079 men were prescribed human chorionic gonadotropin (75.23%; 90.1% of whom used this…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 9,537 participants or records.
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