Effects of testosterone supplementation on depressive symptoms and sexual
dysfunction in hypogonadal men with the metabolic syndrome.
Author(s): Giltay EJ, Tishova YA, Mskhalaya GJ, Gooren LJ, Saad F, Kalinchenko SY.
Affiliation(s): Department of Psychiatry, Leiden University Medical Center, Leiden, the
Netherlands. giltay@dds.nl
Publication date & source: 2010, J Sex Med. , 7(7):2572-82
INTRODUCTION: Low testosterone levels in men are associated with the metabolic
syndrome (MetS) as well as with depressive symptoms, low vitality, and sexual
dysfunction.
AIM: To assess the effects of testosterone administration on these subjective
symptoms, which have not extensively been studied in hypogonadal men with the
MetS.
MAIN OUTCOME MEASURES: The Beck Depression Inventory (BDI-IA), Aging Males'
Symptoms (AMS) scale, and International Index of Erectile Function 5-item
(IIEF-5) scale at baseline, 18 and 30 weeks were analysed using multilevel
analysis.
METHODS: In a randomized, placebo-controlled, double-blind, phase III trial
(ClinicalTrials.gov identifier: NCT00696748), 184 men suffering from both the
MetS and hypogonadism were included. They were treated for 30 weeks with either
parenteral testosterone undecanoate (TU; 1,000 mg IM TU, at baseline, and after 6
and 18 weeks; Nebido or placebo injections, 105 (92.9%) men receiving TU and 65
(91.5%) receiving placebo completed the 30-week trial.
RESULTS: The 184 men were aged mean 52.1 years old (standard deviation [SD] 9.6;
range 35-69), with a mean body mass index of 35.5 kg/m(2) (SD 6.7; range
25.1-54.8), and a mean total testosterone level of 8.0 nmol/L (SD 4.0). There
were significant improvements in BDI-IA (mean difference vs. placebo after 30
weeks: -2.5 points; 95% confidence interval [CI]: -0.9; -4.1; P = 0.003), AMS
(-7.4 points; 95% CI: -4.3; -10.5; P < 0.001), and IIEF-5 (+3.1 points; 95% CI:
+1.8; +4.4; P < 0.001). The effects on the BDI-IA, AMS, and IIEF-5 were strongest
in men with baseline total testosterone levels <7.7 mmol/L (i.e., median value).
CONCLUSIONS: TU administration may improve depressive symptoms, aging male
symptoms and sexual dysfunction in hypogonadal men with the MetS. The beneficial
effects of testosterone were most evident in men with the lowest baseline total
testosterone levels.
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