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Of the 102 patients in the 750 mg arm receiving their fourth injection, 86% had a Cavg within the normal range. No patients in the 750 mg arm exceeded a testosterone level of either 2500 ng/dL or 1800 ng/dL, and only four of 102 (3.9%) patients had a peak level exceeding 1500 ng/dL. For those few patients exceeding the 1500 ng/dL threshold, the duration of time above the threshold was brief.
Both treatment arms demonstrated improvements from baseline in the key secondary clinical outcome variables.
Both doses of the drug were well-tolerated as indicated by the analysis of the safety measurements collected and the persistence with study treatment. Further, the spectrum of adverse events reported were comparable to other injectable hypogonadism treatments reported in the literature. There were no significant adverse changes in laboratory parameters with NEBIDO treatment.
Conference call and webcast
The Company will hold a conference call and webcast to discuss these results at 9:00 a.m. eastern time on June 7, 2007. The live call may be accessed by dialing 800-659-2056 from the U.S. and Canada, and 617-614-2714 from international locations. The participant passcode is 34528470. A replay of the call will be available beginning at 11:00 a.m. on June 7, 2007 and lasting until 12:00 a.m. on July 6, 2007. To access the replay, please dial 888-286-8010 from the U.S. and Canada, and 617-801-6888 from international locations, using the passcode 36218483.
The press release and the live webcast will be accessible by
visiting the Investors section of the Company's
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