Treatment of 161 men with symptomatic late onset hypogonadism with long-acting parenteral testosterone undecanoate: Effects on body composition, lipids, and psychosexual complaints

Abstract

Introduction. Elderly men may suffer from late-onset hypogonadism (LOH). The long-term effects of long-acting testosterone undecanoate (TU) in a large number of LOH men have not yet been reported. Aims. We analyzed the effects of normalization of plasma testosterone (T) in LOH men. Methods. The records of 161 men with LOH (baseline T < 300 ng/dL) were reviewed and 100 men had used parenteral TU for >12 months. The mean duration of treatment was 90.6 weeks (54 to 150 weeks). Main Outcome Measures. Body mass index (BMI), waist circumference, percentage body fat, total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, prostate-specific antigen (PSA), and hematocrit were measured. Further the Aging Male Symptoms' scale (AMS) and the International Index of Erectile Function (IIEF-5 and 15) were scored. Results. T therapy was associated with a significant decline in waist circumference (P = 0.028) and percentage body fat (P < 0.001), but no change of BMI. Total cholesterol and LDL cholesterol declined significantly (P = 0.005 and P = 0.024, respectively), with no significant changes of HDL cholesterol and triglycerides. The scores of sub-scales of AMS (psychological, somotovegetative and sexual factors) decreased (P = 0.044, P = 0.200 and P = 0.071, respectively). The mean IIEF-5 (P = 0.011) and IIEF-15 scores (P = 0.021) improved significantly. Erectile function domain, orgasmic function domain, sexual desire domain, intercourse satisfaction domain, and overall satisfaction domain improved. Median PSA rose from 0.95 (0.640; 1.558) ng/mL to 1.480 (1.015; 2.275) ng/mL (P < 0.001), with 11 patients >4 ng/mL (4.01-13.21). On biopsy there was no evidence for malignancy. The mean hematocrit level increased significantly from 42.3 ± 3.4% to 47.1 ± 3.8%. Conclusions. Normalizing serum T in men with LOH resulted in improvement of the metabolic syndrome, mood and sexual functions and appeared acceptably safe. © 2010 International Society for Sexual Medicine.