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news.Indevus Pharmaceuticals has reported positive data from Phase III study on Nebido, an investigational, long-acting intramuscular injection for the treatment of hypogonadism.
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The study demonstrated that 94% of the men had their testosterone levels restored and maintained to within normal levels; further, 92% of these men expressed satisfaction with their Nebido treatment. Approximately 62% of men participating in the Phase III study had previously used other testosterone treatments.
In the study, pharmacokinetic objectives were achieved, with 94% of patients reaching and maintaining normal serum testosterone levels. Additionally, secondary endpoints of mood and sexual function also improved.
This Phase III study was a multi-center, open-label, randomized US trial 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 300ng/dL, at least 18 years of age) that met the study inclusion criteria. Patients received injections of 750mg of Nebido at baseline, week four, 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.