Efficacy and safety of long‐acting intramuscular testosterone undecanoate in aging men: a randomised controlled study. (12th April 2013)

• Record Type: Journal Article
• Authors: Tan, Wei Shen; Low, Wah Yun; Ng, Chirk Jenn; Tan, Wei Keith; Tong, Seng Fah; Ho, Christopher; Khoo, Ee Ming; Lee, George; Lee, Boon Cheok; Lee, Verna; Tan, Hui Meng
• Is Part Of: BJU international. Volume 111:Number 7(2013:Apr.)
• Page Start: 1130
• Page End: 1140
• Publication Date: 2013-04-12
• Subjects: Genitourinary organs -- Diseases -- Periodicals; Genitourinary organs -- Surgery -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1111/bju.12037
• Languages: English
• ISSNs: 1464-4096

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="bju12037-sec-0001" sec-type="section"> <title>Objective</title> <p> <list id="bju12037-list-0001" list-type="bullet"> <list-item> <p>To evaluate the efficacy and safety of long‐acting i.m. testosterone undecanoate (TU) in Malaysian men with testosterone deficiency (TD).</p> </list-item> </list> </p> </sec> <sec id="bju12037-sec-0002" sec-type="section"> <title>Patients and Methods</title> <p> <list id="bju12037-list-0002" list-type="bullet"> <list-item> <p>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.</p> </list-item> <list-item> <p>In all, 58 and 56 men in the placebo and treatment arm, respectively, completed the study.</p> </list-item> <list-item> <p>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.</p> </list-item> </list> </p> </sec> <sec id="bju12037-sec-0003" sec-type="section"> <title>Results</title> <p> <list id="bju12037-list-0003" list-type="bullet"> <list-item> <p>The mean (<sc>sd</sc>) age of the participants was 53.4 (7.6) years.</p> </list-item> <list-item> <p>A significant increase in serum TT (<italic>P</italic> < 0.001), PSA (<italic>P</italic> = 0.010), haematocrit (<italic>P</italic> < 0.001), haemoglobin (<italic>P</italic> < 0.001) and total bilirubin (<italic>P</italic> = 0.001) were seen in the treatment arm over the 48‐week period.</p> </list-item> <list-item> <p>Two men in the placebo arm and one man in the treatment arm developed myocardial infarction.</p> </list-item> <list-item> <p>Common adverse events observed in the treatment arm included itching/swelling/pain at the site of injection, flushing and acne.</p> </list-item> <list-item> <p>Overall, TU injections were well tolerated.</p> </list-item> </list> </p> </sec> <sec id="bju12037-sec-0004" sec-type="section"> <title>Conclusions</title> <p> <list id="bju12037-list-0004" list-type="bullet"> <list-item> <p>TU significantly increases serum testosterone in men with TD.</p> </list-item> <list-item> <p>PSA, haemoglobin and haematocrit were significantly elevated but were within clinically safe limits.</p> </list-item> <list-item> <p>There was no significant adverse reaction that led to the cessation of treatment.</p> </list-item> </list> </p> </sec> </abstract>