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news.AEterna Zentaris has completed patient recruitment for the company's first efficacy trial of its Phase III program in benign prostatic hyperplasia, with its flagship product candidate, cetrorelix.
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The study involves approximately 600 patients primarily in the US and Canada, with additional sites in Europe. This first efficacy study, a one-year placebo-controlled efficacy study will assess an intermittent dosage regimen of cetrorelix as a safe and tolerable treatment providing prolonged improvement in benign prostatic hyperplasia (BPH)-related signs and symptoms.
Paul Blake, senior vice president and chief medical officer of AEterna Zentaris, said: “We are very proud to have reached this important milestone. The Phase III program in BPH with cetrorelix is on track and we expect to provide results in the third quarter of 2009 as stated previously.”