Effect of long-acting testosterone undecanoate treatment on quality of life in men with testosterone deficiency syndrome: a double blind randomized controlled trial (original) (raw)

Abstract

This study aimed to investigate the effect of intramuscular injection of testosterone undecanoate on overall quality of life (QoL) in men with testosterone deficiency syndrome (TDS). A randomized controlled trial over a 12-month period was carried out in 2009. One hundred and twenty men aged 40 years and above with a diagnosis of TDS (serum total testosterone, <12 nmol l(-1) and total Aging Male Symptom(AMS) scores >= 27) were invited to participate. Interventions comprised intramuscular injection of either placebo or 1000 mg testosterone undecanoate, given at weeks 0, 6, 18, 30 and 42. This paper presents the secondary analysis of QoL changes measured in the scores of Short-Form-12 (SF-12) scale at baseline, weeks 30 and 48 after the first injection. A total of 56/60 and 58/60 men from the active treatment and placebo group, respectively, completed the study. At week 48, before adjusting for baseline differences, the QoL of men in the treatment group improved significantly in five out of the eight domains on SF-12. The physical health composite scores improved 4.0 points from a baseline of 41.9 +/- 7.0 in the treatment group compared to 0.8 point from a baseline of 43.7 +/- 7.1 in the placebo group (F=3.652, P=0.027). The mental health composite scores improved 4.4 points from a baseline of 37.1 +/- 9.0 in the treatment group compared to 1.0 points from a baseline of 37.6 +/- 7.9 in the placebo group (F=4.514, P=0.018). After adjusting for baseline differences, significant improvement was observed in mental health composite scores, but not in physical health composite scores. Long-acting testosterone undecanoate significantly improved the mental health component of QoL in men with TDS. Asian Journal of Andrology (2012) 14, 604-611; doi:10.1038/aja.2011.178; published online 28 May 2012

Figures (7)

Figure 1 Progress of participants involvement in the study. AMS, Aging Male Symptom; PSA, prostate-specific antigen. MI, myocardial infarction; TT, total testosterone. The baseline characteristics for both groups were comparable except for metabolic parameters and AMS scores (Table 1). The body mass index, waist circumference and diastolic blood pressure were

Figure 1 Progress of participants involvement in the study. AMS, Aging Male Symptom; PSA, prostate-specific antigen. MI, myocardial infarction; TT, total testosterone. The baseline characteristics for both groups were comparable except for metabolic parameters and AMS scores (Table 1). The body mass index, waist circumference and diastolic blood pressure were

Table 1 Baseline characteristics of the two groups Abbreviations: AMS, Aging Male Symptoms; SHBG, serum hormone-binding globulin. * Data expressed as mean+s.d. > Data expressed as n (%).

Table 1 Baseline characteristics of the two groups Abbreviations: AMS, Aging Male Symptoms; SHBG, serum hormone-binding globulin. * Data expressed as mean+s.d. > Data expressed as n (%).

Figure 2 Mean serum total testosterone (with 95% Cl) level during the trial period. *P<0.001, compared to baseline; t+ P<0.001, compare to placebo group. Serum TT levels increased significantly in both placebo and active treatment groups. In the placebo group, mean TT slightly increased from 9.1 at baseline to 11.2 nmol 17! at week 48 (F=12.527, P<0.001), whereas in the active treatment group, mean TT significantly increased from 8.9 at baseline to 23.7 nmol 17! at week 48 (F=181.273, P<0.001). The significant increase in the placebo group occurred within the first 18 weeks (TT=11.4 nmol |~!, F=12.527, P<0.001) and it reached a plateau thereafter; however, the levels remained below 12 nmol!” '. On the other hand, mean TT in the active treatment group raised to the normal range (>12 nmol 1!) after week 18 and continued to increase up to week 48. The increase in active treatment group over 18 and 48 weeks is significant compared to placebo group (F=62.001, P<0.001) (Figure 2).

Figure 2 Mean serum total testosterone (with 95% Cl) level during the trial period. *P<0.001, compared to baseline; t+ P<0.001, compare to placebo group. Serum TT levels increased significantly in both placebo and active treatment groups. In the placebo group, mean TT slightly increased from 9.1 at baseline to 11.2 nmol 17! at week 48 (F=12.527, P<0.001), whereas in the active treatment group, mean TT significantly increased from 8.9 at baseline to 23.7 nmol 17! at week 48 (F=181.273, P<0.001). The significant increase in the placebo group occurred within the first 18 weeks (TT=11.4 nmol |~!, F=12.527, P<0.001) and it reached a plateau thereafter; however, the levels remained below 12 nmol!” '. On the other hand, mean TT in the active treatment group raised to the normal range (>12 nmol 1!) after week 18 and continued to increase up to week 48. The increase in active treatment group over 18 and 48 weeks is significant compared to placebo group (F=62.001, P<0.001) (Figure 2).

Table 2 Comparing the SF-12 domain scores for quality of life (QoL) between placebo and active treatment arms over time Abbreviations: A, active treatment; P, placebo. *Comparing between two intervention groups over time by including the interaction term of ‘intervention xtime’. **Adjusted for baseline BMI, SBP, DBP and total AMS scores differences.

Table 2 Comparing the SF-12 domain scores for quality of life (QoL) between placebo and active treatment arms over time Abbreviations: A, active treatment; P, placebo. *Comparing between two intervention groups over time by including the interaction term of ‘intervention xtime’. **Adjusted for baseline BMI, SBP, DBP and total AMS scores differences.

Figure 3 Changes from baseline score in the eight domains of SF-12. QoL, quality of life.

Figure 3 Changes from baseline score in the eight domains of SF-12. QoL, quality of life.

Figure 4 Changes from baseline (with 95% Cl) inthe composite scores of SF-12. QoL, quality of life; SF-12, Short-Form-12. Serum TT was measured at weeks 18 and 48 after the first injection. In the active treatment group, we noted that the serum TT was higher

Figure 4 Changes from baseline (with 95% Cl) inthe composite scores of SF-12. QoL, quality of life; SF-12, Short-Form-12. Serum TT was measured at weeks 18 and 48 after the first injection. In the active treatment group, we noted that the serum TT was higher

Table 3 Biochemical parameters with significant increases between placebo and active treatment arm (Nebido) Abbreviation: PSA, prostate-specific antigen.

Table 3 Biochemical parameters with significant increases between placebo and active treatment arm (Nebido) Abbreviation: PSA, prostate-specific antigen.

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