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Indevus Presents Successful Phase III NEBIDO(R) Data at American Urological Association
Date:5/20/2008

rcentage of men who received this treatment maintained normal testosterone levels while receiving an injection every 10 weeks. This form of testosterone treatment would thus require only five injections per year. This would be an appealing alternative for many men, who may object to existing testosterone treatments such as twice-monthly injections or daily skin application of gels or patches."

About the Study

This Phase III study was a multi-center, open-label, randomized US trial designed to assess the pharmacokinetics, safety, and efficacy of NEBIDO in men with primary or secondary hypogonadism. The trial enrolled a total of 130 hypogonadal men (serum testosterone below 300 ng/dL, at least 18 years of age) that met the study inclusion criteria. Patients received injections of 750 mg of NEBIDO at baseline, week 4, and week 14 of the study, and were followed for an additional 10 weeks. Of the 130 men who participated in the trial, 117 patients were eligible for pharmacokinetics evaluations.

In the study, pharmacokinetic objectives were achieved, with 94 percent of patients reaching and maintaining normal serum testosterone levels. Additionally, secondary endpoints of mood and sexual function also improved. The most commonly reported possibly-related adverse events in the trial were acne (4.6 percent), fatigue (3.1 percent), and injection site pain (3.1 percent).

About NEBIDO

NEBIDO(R) is a long-acting depot preparation of testosterone undecanoate, developed for the treatment of male hypogonadism. NEBIDO is expected to be the first long-acting testosterone preparation available in the U.S. in the growing market for testosterone therapies. Indevus acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

About Hypogonadism

Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Today, there are an estimate
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SOURCE Indevus Pharmaceuticals, Inc.
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