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Testosterone Undecanoate Achieves and Maintains Normal Testosterone Levels in Hypogonadal Men With Five Injections Per Year, New Data Show
Date:4/28/2009

bel study enrolled 130 hypogonadal men with serum testosterone levels below 300 ng/dL at study entry. NEBIDO was dosed as an intramuscular injection (750 mg) at baseline, at week four, and then every 10 weeks throughout the remainder of the 21-month study. Approximately 70 percent of patients completed all NEBIDO injections.

Evaluation of testosterone levels showed that average concentrations were consistent from one injection to the next.

Safety data showed that NEBIDO was generally well tolerated over the 21-month study, with reported side effects typically characterized as mild and non-serious. The most common side effects reported were acne (6.2 percent) and increased prostate specific antigen (5.4 percent).

Dr. Morgentaler noted: "Because men who suffer from hypogonadism need to remain on treatment for life, it is very important that they can have a treatment option that is well tolerated. Transdermal patches and gels that must be applied to the skin on a daily basis can be effective when used appropriately, but they are associated with variable patient compliance and may require extra care to prevent transfer of topical testosterone to partners or children. Long-term injections may offer hypogonadal men a convenient new option."

ABOUT HYPOGONADISM

Hypogonadism, also known as low testosterone, is a common yet largely under-recognized and under-treated condition that affects an estimated 13.8 million men in the United States. Only 9 percent of American men with low testosterone are currently being treated with testosterone replacement therapy.

Low testosterone is associated with a broad range of physical, psychological and sexual symptoms including decreased energy and mood, fatigue, loss of muscle mass, decreased libido and erectile dysfunction. In addition, low testosterone is associated with other serious medical conditions including di
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SOURCE Endo Pharmaceuticals
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