Document Detail


A safety study of administration of parenteral testosterone undecanoate to elderly men over minimally 24 months.
MedLine Citation:
PMID:  21105885     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
This study investigated the safety of administration of long-acting parenteral testosterone undecanoate (TU) to 122 hypogonadal, mainly elderly men, aged 59.6 ± 8.0 years (range 18-83 years old), with baseline testosterone levels between 5.8 and 12.1 nmol l(-1) (mean ± SD = 9.3 ± 1.7). Patients were followed for 24 months. Plasma testosterone rose from 9.3 ± 1.7 to 14.9 ± 4.5 nmol l(-1) (P< 0.01) at 3 months, then stabilised at 19.2 ± 4.6 nmol l(-1) after 6 months. International Prostate Symptoms Scores and Residual Bladder Volumes decreased significantly (P <0.01) over the study period. Prostate volume and prostate-specific antigen levels fluctuated over the study period but had not increased significantly after 24 month. Haemoglobin concentrations increased significantly (P < 0.001) over the 24 months while the haematocrit increased significantly (P < 0.001) during the first 15 months and then levelled off. Statistical analysis with expressing values as means ± SD masks excesses above reference values of individual patients. These excesses were noted in low numbers, were permanently present in some but not in other individuals, and did not increase in number over the 24 month study period. Over 24 months treatment with TU appeared acceptably safe, but longer and larger scale studies are needed.
Authors:
A Haider; L J G Gooren; P Padungtod; F Saad
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Andrologia     Volume:  42     ISSN:  1439-0272     ISO Abbreviation:  Andrologia     Publication Date:  2010 Dec 
Date Detail:
Created Date:  2010-11-25     Completed Date:  2011-02-24     Revised Date:  2011-12-20    
Medline Journal Info:
Nlm Unique ID:  0423506     Medline TA:  Andrologia     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  349-55     Citation Subset:  IM    
Copyright Information:
© 2010 Blackwell Verlag GmbH.
Affiliation:
Private Urology Praxis, Bremerhaven, Germany.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adult
Aged
Humans
Hypogonadism / drug therapy
Male
Middle Aged
Polycythemia / chemically induced
Prostate-Specific Antigen / blood
Testosterone / administration & dosage,  analogs & derivatives*,  blood,  toxicity
Chemical
Reg. No./Substance:
58-22-0/Testosterone; 5949-44-0/testosterone undecanoate; EC 3.4.21.77/Prostate-Specific Antigen

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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