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.