Efficacy and safety of long‐acting intramuscular testosterone undecanoate in aging men: a randomised controlled study

Abstract

Objective• To evaluate the efficacy and safety of long-acting i.m.testosterone undecanoate (TU) in Malaysian men with testosterone deficiency (TD). Patients and Methods• A total of 120 men, aged 40-70 years, with TD (serum total testosterone [TT] Յ 12 nmol/L) were randomised to receive either i.m. TU (1000 mg) or placebo.• In all, 58 and 56 men in the placebo and treatment arm, respectively, completed the study.• Participants were seen six times in the 48-week period and the following data were collected: physical examination results, haemoglobin, haematocrit, TT, lipid profile, fasting blood glucose, sex hormone-binding globulin, liver function test, prostate-specific antigen (PSA) and adverse events. Results• The mean (SD) age of the participants was 53.4 (7.6) years.• A significant increase in serum TT (P < 0.001), PSA (P = 0.010), haematocrit (P < 0.001), haemoglobin (P < 0.001) and total bilirubin (P = 0.001) were seen in the treatment arm over the 48-week period.• Two men in the placebo arm and one man in the treatment arm developed myocardial infarction.• Common adverse events observed in the treatment arm included itching/swelling/pain at the site of injection, flushing and acne.• Overall, TU injections were well tolerated. Conclusions• TU significantly increases serum testosterone in men with TD. • PSA, haemoglobin and haematocrit were significantly elevated but were within clinically safe limits.• There was no significant adverse reaction that led to the cessation of treatment.

THERAPY OF ENDOCRINE DISEASE: Testosterone supplementation and body composition: results from a meta-analysis study

“…an increase in lean mass and a reduction in fat mass, might justify the overall null efficacy of TS on body weight or BMI. Present results are in apparent contrast with several observational studies indicating that TS is associated with a significant weight loss (62,64,65,66,67,68,69) and decrease in BMI (64,66,68,69,126,128) and WC (60,64,66,67,68,69,113,123,128). RCTs and observational studies obviously differ in study design and patient allocation criteria.…”

Critical Update of the 2010 Endocrine Society Clinical Practice Guidelines for Male Hypogonadism

“…The authors actually noted a small improvement in IPSS scores in the TRT arm (mean AE SD effect: À2.41AE6.02 for TRT vs 1.62AE7.58 for placebo; P¼.540), but they did not perform a separate analysis restricted to patients with severe-range LUTS. 16 Although the literature does not yet adequately address severe IPSS specifically, the data seem to refute, or at least challenge, the traditionally held belief that TRT may exacerbate voiding symptoms and suggest that this recommendation may need to be reexamined.…”

“…Furthermore, Tan et al, 16 in a trial of 114 hypogonadal men treated with injectable testosterone for 48 weeks, noted that 14.9% of their cohort exhibited baseline severe-range LUTS, as measured by the IPSS, without any difference in prevalence between the 2 treatment arms. The authors actually noted a small improvement in IPSS scores in the TRT arm (mean AE SD effect: À2.41AE6.02 for TRT vs 1.62AE7.58 for placebo; P¼.540), but they did not perform a separate analysis restricted to patients with severe-range LUTS.…”

“…A nonsignificant increase (improvement) in the overall IIEF score was also observed (mean AE SD effect, 2.31AE4.80 for TRT vs À0.95AE4.57 for placebo; P¼.130). 16,25 Additional studies of the effects of TRT on QoL and other end points were conducted by Pope et al 26 These authors examined 100 hypogonadal men with major depression refractory to selective serotonin reuptake inhibitors. Patients were treated with testosterone gel or placebo for 6 weeks.…”

Hypogonadism in Male Sexual Dysfunction

“…• Obstructive sleep apnea, classically considered a contraindication for testosterone treatment, because of neutral studies, with no worsening of the disease [125][126][127] • Lower urinary tract symptoms, which do not worsen under testosterone treatment, as classically considered [128][129][130] • Congestive heart failure is still a relative contraindications for replacement treatment, but controversial, since excellent results are seen in testosterone treatment in cases with well controlled congestive heart failure [131]. Maybe untreated/uncontrolled heart failure should be considered as a contraindication.…”