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Intramuscular Injections of Testosterone Undecanoate Restores and Maintains Testosterone Levels in Hypogonadal Men: Presented at AUA
By Deborah Brauser
ORLANDO, Fla -- May 27, 2008 -- Intramuscular injections of long-acting testosterone undecanoate appear to restore and maintain normal testosterone levels in a significantly high number of phase 3 study patients suffering from hypogonadism, according to research presented here at the American Urological Association (AUA) Annual Meeting.
Abraham Morgentaler, MD, Associate Clinical Professor of Urology, Harvard Medical School, Boston, Massachusetts, reported the results in a late-breaking news presentation on May 20.
This phase 3, multicentre, open-label, randomised trial was designed to assess the safety, efficacy, and pharmacokinetics of testosterone undecanoate intramuscular injections. In the study, men with hypogonadism and low serum testosterone levels were treated with 3 intramuscular injections of testosterone undecanoate every 10 weeks.
"This form of testosterone treatment would require only 5 injections per year," said Dr. Morgentaler, "[making it] an appealing alternative for many men who may object to existing testosterone treatments such as twice-monthly injections or daily skin applications."
In the trial, 130 men aged at least 18 years who had serum testosterone levels <300 ng/dL received intramuscular testosterone undecanoate at a dose of 750 mg at baseline, at week 4, and at week 14. They were followed for an additional 10 weeks.
At the end of the study, 94% of patients reached and maintained normal serum testosterone levels.
Adverse events reported by patients included acne (4.6%), fatigue (3.1%), and injection site pain (3.1%).
"If approved, this may be very good for treating men with hypogonadism. No treatment is perfect. Pills often lead to concerns about liver problems and while 75% of patients use gels, most don't like it. A long-lasting injection means longer-lasting help," said Dr. Morgentaler.
[Presentation title: Safety, Efficacy, and Pharmacokinetics of Testosterone Undecanoate Long-Acting Injection of Hypogonadism: Results of a Phase III Clinical Trial.]
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