Effect of oral testosterone undecanoate on visuospatial cognition, mood and quality of life in elderly men with low-normal gonadal status

Objectives: The effects of supplemental testosterone on cognition, mood and wellbeing in ageing men are unclear. This study aimed to assess the effect of 12-months of oral testosterone supplementation on cognitive function, mood and quality of life in elderly men with low-normal gonadal status, not specifically selected for cognitive or mood defects. Methods: A standard oral dose (80 mg twice daily) of testosterone undecanoate (TU) or placebo was administered for one year to 76 healthy men 60 years or older. All men had a free testosterone index (FTI) of 0.3-0.5, which represents a value below the normal lower limit for young men (19-30 years), but remains within the overall normal male range. A neuropsychological assessment including the trail making test (part B), visuospatial (VSP) block design test, mini mental state exam (MMSE), Geriatric Depression Scale (GDS), a 5-point Likert and a 10-point visual analogue quality of life (QoL) scale, along with serum hormone measurements were obtained at baseline, 6, and 12 months. Results: Although calculated bioavailable testosterone (cBT) and FTI were higher, and muscle mass increased after 12 months, there was no difference in scores on the trail making or VSP block tests, the MMSE, GDS or either of the QoL scales between the testosterone and placebo group. There was no relationship between baseline cBT or FTI and treatment effect for any of the outcome measures. Conclusions: 12-month supplementation with oral TU does not affect scores on visuospatial tests or mood and quality of life scales in older men with low-normal gonadal status. (C) 2004 Elsevier Ireland Ltd. All rights reserved.