Effects of long-acting testosterone undecanoate on health-related quality of life in hypogonadal men: results of a randomized, double-blind study
A randomized, double-blind, placebo-controlled trial on the effect of long-acting testosterone treatment as assessed by the Aging Male Symptoms scale. Ho CC, Tong SF, Low WY, et al. BJU Int 2012; 110(2): 260-265.
This randomized, double-blind, placebo-controlled study evaluated the effect of long-acting testosterone treatment in Malaysian men with low testosterone levels, assessing treatment effects using the Aging Male Symptoms (AMS) scale.1 The participants in this single-centre study were aged 40−70 years and had at least mild symptoms on all three AMS scale subdomains (somatovegetative domain score ≥9, psychological domain score ≥6, sexual domain score ≥6) or total AMS score ≥27, and an early morning total testosterone level of ≤12 nmol/L (346 ng/dL). Participants were randomized 1:1 to receive long-acting injectable testosterone undecanoate 1000 mg (n=60) or placebo injection in an identical form (n=60) at weeks 0, 6, 18, 30 and 42 after formal enrolment. Participants were assessed at baseline and at 18 and 48 weeks after initial intramuscular injection, and the effects of treatment were assessed using repeated measure ANOVA.1 At baseline the mean total AMS score was 38.46±11.85 for the placebo group and 41.73±12.73 for the treatment group.
What is known
Low testosterone levels, common in older men, are associated with a range of physical, psychological and sexual symptoms, and testosterone treatment has been shown to improve these symptoms and health-related quality of life (HRQoL).2,3 The Aging Male Symptoms (AMS) scale is one tool for assessing HRQoL in hypogonadal men.4 The scale is a subjective measure of the severity of aging symptoms and comprises 17 items on a scale of 1−5, with a higher score meaning greater symptom severity (overall score ranges from 17 to 85). Studies have shown that the AMS scale correlates with testosterone levels and predicts hypogonadism, and can measure treatment effects on HRQoL.5-7 The AMS scale has not been widely used to report the effect of testosterone therapy in late-onset hypogonadism.
What this study adds
This randomized, double-blind, placebo-controlled study confirmed that long-acting testosterone undecanoate is effective in improving HRQoL in men with testosterone deficiency as assessed by the AMS rating scale. Testosterone treatment significantly improved HRQoL compared with placebo in the study population of Malaysian hypogonadal men.1 The results are in line with other published studies in Asian and European men reporting the effects of long-acting testosterone undecanoate using the AMS rating scale.3,8-10