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

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 21 and total Aging Male Symptom (AMS) scores o27) 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 41.967.0 in the treatment group compared to 0.8 point from a baseline of 43.767.1 in the placebo group (F53.652, P50.027). The mental health composite scores improved 4.4 points from a baseline of 37.169.0 in the treatment group compared to 1.0 points from a baseline of 37.667.9 in the placebo group (F54.514, P50.018). 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.

Efficacy and safety of long‐acting intramuscular testosterone undecanoate in aging men: a randomised controlled study

“…TU significantly increased serum TT level in aging Malaysian men and was safe and well tolerated. Results on the effect of TU using the Aging Male Symptoms score and on quality of life in the present study have been reported previously . The present study is one of the few double‐blind placebo‐controlled trials involving Asian men.…”

“…This study was part of a bigger randomised placebo-controlled trial. The efficacy of TU in improving symptoms of TD has been reported previously [18].…”

Health-related physical fitness and quality of life in men with congenital hypogonadotropic hypogonadism

“…Additionally, Tong et al. evaluated the influence of a long‐acting testosterone formulation in hypogonadal men QOL and observed a significant improvement in mental health after 30 weeks of treatment (Tong, Ng, Lee, & Lee, ). Although the QOL findings presented in Table do not allow the establishment of a link between TRT and QOL, which involves a range of interfering factors, they agree with Tong and collaborators' conclusions.…”

Testosterone Therapy and Cardiovascular Risk: Advances and Controversies

“…Established benefits of T therapy in hypogonadal men include improved sexual desire and function, [12][13][14][15] improved energy, mood, and vitality, [15][16][17][18][19] increased lean mass, 14,[19][20][21][22] decreased waist circumference, [23][24][25][26][27] reduced total body fat mass, [19][20][21][22] and increased bone mineral density. [28][29][30][31] Promising new data reveal that T therapy improves insulin sensitivity [32][33][34] and reduces blood glucose 23,25,35 and hemoglobin A 1c (HbA 1c ) 23,25,27,35 levels in men with type 2 diabetes or obesity.…”