A randomized, double‐blind, placebo‐controlled trial on the effect of long‐acting testosterone treatment as assessed by the Aging Male Symptoms scale

Abstract

Study Type - Therapy (RCT). Level of Evidence 1b. What's known on the subject? and What does the study add? Testosterone deficiency syndrome can be treated with testosterone replacement in the form of injectable, transdermal, buccal and oral preparations. Long-acting i.m. testosterone undecanoate 1000 mg, which is given at 10-14 week intervals, has been shown to be adequate for sustaining normal testosterone levels in hypogonadal men. This study confirms that long-acting i.m. testosterone undecanoate is effective in improving the health-related quality of life in men with testosterone deficiency syndrome as assessed by the improvement in the Aging Male Symptoms scale. Testosterone treatment can be indicated in men who have poor health-related quality of life resulting from testosterone deficiency syndrome. • To evaluate the effect of i.m. injection of testosterone undecanoate 1000 mg over 12 months on the Aging Male Symptom (AMS) scale scores in men with testosterone deficiency syndrome (TDS). • A total of 120 men >40 years old with TDS (total testosterone < 12 nmol/L and total AMS scores ≥ 27) were randomized into i.m. injection of either placebo or testosterone undecanoate 1000 mg. • In all, 56 and 58 participants from the active treatment and placebo groups, respectively completed the study. • An i.m. injection of either placebo or testosterone undecanoate 1000 mg was given at weeks 0, 6, 18, 30 and 48. • Self-administered AMS questionnaires were completed at weeks 0, week 18 and week 48. • Improvement in the total AMS score was significantly greater in the treatment group than in the placebo group (F: 4.576, P= 0.017) over the 48-week period. • The mean (sd) total AMS score was 38.46 (11.85) at baseline and 33.59 (1.69) at 48 weeks for the placebo group, and 41.73 (12.73) at baseline and 32.61 (9.67) at 48 weeks for the treatment group. • The mean change in the total AMS score was -12.6% in the placebo group and -21.9% in the treatment group. • The mean psychological and somatovegetative domain scores decreased significantly more in the treatment group than in the placebo group (-2.8 vs -1.2, P= 0.03; and -3.2 vs -1.8, P= 0.016). • The difference in change between the randomized groups for the sexual domain scores followed the same trend, though the difference was not significant. • Long-acting testosterone is effective in improving health-related quality of life as assessed by the AMS scale in men with TDS.