Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study
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 <= 12 nmol/L) were randomised to receive either i.m....
Saved in:
Main Authors: | , , , , , , , , , , |
---|---|
Format: | Article |
Published: |
Wiley
2013
|
Subjects: | |
Online Access: | http://eprints.um.edu.my/10024/ http://onlinelibrary.wiley.com/doi/10.1111/bju.12037/full |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
id |
my.um.eprints.10024 |
---|---|
record_format |
eprints |
spelling |
my.um.eprints.100242017-07-14T08:12:25Z http://eprints.um.edu.my/10024/ Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study Tan, W.S. Low, W.Y. Ng, C.J. Tan, W.K. Tong, S.F. Ho, C. Khoo, E.M. Lee, G. Lee, B.C. Lee, V. Tan, H.M. R Medicine RA Public aspects of medicine 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 <= 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. Wiley 2013 Article PeerReviewed Tan, W.S. and Low, W.Y. and Ng, C.J. and Tan, W.K. and Tong, S.F. and Ho, C. and Khoo, E.M. and Lee, G. and Lee, B.C. and Lee, V. and Tan, H.M. (2013) Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study. BJU International, 111 (7). pp. 1130-1140. ISSN 1464-4096 http://onlinelibrary.wiley.com/doi/10.1111/bju.12037/full 10.1111/bju.12037 |
institution |
Universiti Malaya |
building |
UM Library |
collection |
Institutional Repository |
continent |
Asia |
country |
Malaysia |
content_provider |
Universiti Malaya |
content_source |
UM Research Repository |
url_provider |
http://eprints.um.edu.my/ |
topic |
R Medicine RA Public aspects of medicine |
spellingShingle |
R Medicine RA Public aspects of medicine Tan, W.S. Low, W.Y. Ng, C.J. Tan, W.K. Tong, S.F. Ho, C. Khoo, E.M. Lee, G. Lee, B.C. Lee, V. Tan, H.M. Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study |
description |
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 <= 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. |
format |
Article |
author |
Tan, W.S. Low, W.Y. Ng, C.J. Tan, W.K. Tong, S.F. Ho, C. Khoo, E.M. Lee, G. Lee, B.C. Lee, V. Tan, H.M. |
author_facet |
Tan, W.S. Low, W.Y. Ng, C.J. Tan, W.K. Tong, S.F. Ho, C. Khoo, E.M. Lee, G. Lee, B.C. Lee, V. Tan, H.M. |
author_sort |
Tan, W.S. |
title |
Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study |
title_short |
Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study |
title_full |
Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study |
title_fullStr |
Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study |
title_full_unstemmed |
Efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study |
title_sort |
efficacy and safety of long-acting intramuscular testosterone undecanoate in aging men: a randomised controlled study |
publisher |
Wiley |
publishDate |
2013 |
url |
http://eprints.um.edu.my/10024/ http://onlinelibrary.wiley.com/doi/10.1111/bju.12037/full |
_version_ |
1643688687789146112 |
score |
13.18916 |