Effects of testosterone supplementation on depressive symptoms and sexual dysfunction in hypogonadal men with the metabolic syndrome.
BACKGROUND
Low testosterone levels in men are associated with the metabolic syndrome (MetS) as well as with depressive symptoms, low vitality, and sexual dysfunction.


OBJECTIVE
To assess the effects of testosterone administration on these subjective symptoms, which have not extensively been studied in hypogonadal men with the MetS.


METHODS
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.
Department of Psychiatry, Leiden University Medical Center, Leiden, the Netherlands. giltay@dds.nl
Erik J
EJ
Giltay
Yuliya A
YA
Tishova
George J
GJ
Mskhalaya
Louis J G
LJ
Gooren
Farid
F
Saad
Svetlana Y
SY
Kalinchenko
D000328:Adult; D000367:Age Factors; D000368:Aged; D000375:Aging; D000728:Androgens / Q000008:administration & dosage / Q000627:therapeutic use*; D000928:Antidepressive Agents / Q000627:therapeutic use; D016001:Confidence Intervals; D003863:Depression / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D004311:Double-Blind Method; D006801:Humans; D007006:Hypogonadism / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D007262:Infusions, Intravenous; D007263:Infusions, Parenteral; D008297:Male; D024821:Metabolic Syndrome / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D008875:Middle Aged; D015999:Multivariate Analysis; D011594:Psychometrics; D011619:Psychotropic Drugs / Q000627:therapeutic use; D012044:Regression Analysis; D013223:Statistics as Topic; D018709:Statistics, Nonparametric; D011795:Surveys and Questionnaires; D013739:Testosterone / Q000008:administration & dosage / Q000627:therapeutic use*
D000728:Androgens; D000928:Antidepressive Agents; D011619:Psychotropic Drugs; D013739:Testosterone