Largest international trial indicates that testosterone therapy is an effective and well tolerated treatment for male hypogonadism
08 December 2010
IPASS: Final data from the worldwide largest study of the tolerability and effectiveness of injectable testosterone undecanoate (TU) for the treatment of male hypogonadism involving 1493 patients. M Zitzmann, JU Hanisch, A Mattern, M Maggi. A presentation to the Men’s Health World Congress, 2010.
What is known
Systematic reviews of randomized, placebo-controlled clinical trials of testosterone in men, including older men (aged 60 years and over) and middle-aged men, with sexual dysfunction and hypogonadism have shown large favourable effects on libido, but moderate effects on satisfaction with erectile function.3,4,5,6,7
Outcomes in clinical trials of the effect of testosterone treatment on mood have varied. However, there has been evidence that testosterone treatment results in improvements in mood, particularly in older men with hypogonadism.8,9
The benefits of testosterone treatment on body composition have consistently been demonstrated in clinical studies of testosterone therapy in hypogonadal men or men with borderline low testosterone levels.3,9,10,11,12
What this study adds
The effectiveness of testosterone, shown previously in randomised placebo-controlled trials, has now been confirmed in a large, unselected patient cohort drawn from clinical practices around the world.
Clinically relevant and beneficial efficacy has been documented especially regarding sexual function and waist circumference.2 Mean body weight in patients also decreased under TU therapy.1 By the end of the trial those men reporting high or very high levels of sexual desire increased to 61% from a 10% baseline.
At baseline 36 per cent of men reported a “very negative” or “negative” mood. This fell to 5 per cent after the fifth injection.