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.

Key Points1

  • Of 60 participants, 56 testosterone recipients and 58 placebo recipients completed the study
  • Mean serum total testosterone increased from 256.5 ng/dL (8.9 nmol/L) at baseline to 685.9 ng/dL (23.8 nmol/L) at week 48 in the treatment arm and from to 262.3 ng/dL (9.1 nmol/L) to 322.8 ng/dL (11.2 nmol/L) in the placebo arm (p<0.001 vs testosterone)
  • The improvement in total AMS score from baseline (assessed at 18 and 48 weeks) was significantly greater in the treatment arm than the placebo arm (p=0.017) (Figure 1)
  • In absolute terms, the mean change from baseline in total AMS score was -21.9% in the testosterone group and -12.6% in the placebo group
  • There were significantly greater improvements in somatovegetative and psychological subdomain scores for testosterone recipients versus placebo recipients (p<0.001 and p=0.030, respectively) but the difference in improvements in sexual subdomain scores did not reach statistical significance (p=0.092) (Figure 1)
  • Two men died during the study, both from myocardial infarction (one each in the treatment and placebo groups); both had a prior history of ischaemic heart disease
  • Secondary endpoints, including adverse events, will be reported in a separate publication.

What is known

Low testosterone levels, common in older men, are associated with a range of physical, psychological and sexual symptoms, and testosterone replacement treatment (TRT) 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

Figure 1: Improvement in AMS scale score from baseline to week 48

References

1. Ho CC, Tong SF, Low Wy, et al. A randomized, double-blind, placebo-controlled trial on the effect of long-acting testosterone treatment as assessed by the Aging Male Symptoms scale. BJU International 2011; Published ahead of print November 17, doi: 10.1111/j.1464-410X.2011.10755.x.
2. Yassin A, Saad F. Treatment of sexual dysfunction of hypogonadal patients with long-acting testosterone undecanoate (Nebido®). World J Urol 2006; 24(6):639-644.
3. Moon du G, Park MG, Lee SW, et al. The efficacy and safety of testosterone undecanoate (Nebido®) in testosterone deficiency syndrome in Korean: a multicenter prospective study. J Sex Med 2010; 7(6):2253-2260.
4. Heinemann LA, Zimmermann T, Vermeulen A, Thiel C. A new ‘Aging Male’s Symptoms’ (AMS) rating scale. Aging Male 1999; 2:105-114.
5. Heinemann LA, Saad F, Heinemann K, Thai DM. Can results of the Aging Males’ Symptoms (AMS) scale predict those of screening scales for androgen deficiency? Aging Male 2004; 7(3):211-218.
6. Morley JE, Perry HM, Kevorkian RT, Patrick P. Comparison of screening questionnaires for the diagnosis of hypogonadism. Maturitas 2006; 53(4):424-429.
7. Kratzik CW, Reiter WJ, Riedl AM, et al. Hormone profiles, body mass index and aging male symptoms: results of the Androx Vienna Municipality study. Aging Male 2004; 7(3):188-196.
8. Giltay EJ, Tishova YA, Mskhalaya GJ, et al. Effects of testosterone supplementation on depressive symptoms and sexual dysfunction in hypogonadal men with the metabolic syndrome. J Sex Med 2010; 7(7):2572-2582.
9. Aversa A, Bruzziches R, Francomano D, et al. Efficacy and safety of two different testosterone undecanoate formulations in hypogonadal men with metabolic syndrome. J Endocrinol Invest 2010; 33(11):776-783.
10. Permpongkosol S, Tantirangsee N, Ratana-olarn K. Treatment of 161 men with symptomatic late onset hypogonadism with long-acting parenteral testosterone undecanoate: effects on body composition, lipids, and psychosexual complaints. J Sex Med 2010; 7(11):3765-3774.

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