title: 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).
  
  
  METHODS
  A total of 120 men, aged 40-70 years, with TD (serum total testosterone [TT] ≤ 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.
authors: Division of Surgery and Interventional Science, University College London, 74 Huntley St., London, UK. tanweishen@hotmail.com
authors: Wei Shen
authors: WS
authors: Tan
authors: Wah Yun
authors: WY
authors: Low
authors: Chirk Jenn
authors: CJ
authors: Ng
authors: Wei Keith
authors: WK
authors: Tan
authors: Seng Fah
authors: SF
authors: Tong
authors: Christopher
authors: C
authors: Ho
authors: Ee Ming
authors: EM
authors: Khoo
authors: George
authors: G
authors: Lee
authors: Boon Cheok
authors: BC
authors: Lee
authors: Verna
authors: V
authors: Lee
authors: Hui Meng
authors: HM
authors: Tan
mesh_terms: D000328:Adult; D000368:Aged; D000375:Aging / Q000378:metabolism*; D000728:Androgens / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D001663:Bilirubin / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D004311:Double-Blind Method; D005215:Fasting / Q000097:blood; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007273:Injections, Intramuscular / Q000009:adverse effects; D007610:Kallikreins / Q000097:blood; D008055:Lipids / Q000097:blood; D008296:Malaysia / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010808:Physical Examination; D017430:Prostate-Specific Antigen / Q000097:blood; D012738:Sex Hormone-Binding Globulin / Q000378:metabolism; D013739:Testosterone / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood* / Q000172:deficiency / Q000494:pharmacology / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000728:Androgens; D001786:Blood Glucose; D006454:Hemoglobins; D008055:Lipids; D012738:Sex Hormone-Binding Globulin; D013739:Testosterone; C549870:KLK3 protein, human; D007610:Kallikreins; D017430:Prostate-Specific Antigen; C010792:testosterone undecanoate; D001663:Bilirubin