The overall CAMUS (Complementary and Alternative Medicine for Urologic Symptoms) trial is fully functional and well underway. It has successfully randomized 369 participants, more than the 350 initially targeted;however, recruitment took longer than the six months initially expected so that the protocol specified treatment period for the last participants now extends beyond the current funding period, which ends March 31, 2010. The first participant is scheduled to complete follow-up in December 2009 and the last in September 2010. CAMUS is a randomized, double-blind, two arm trial with 369 participants, approximately equally allocated to either the Serenoa repens extract or placebo over a 72 weeks period in escalating doses over three consecutive 24 week periods, beginning with 320 mg, then 640 mg and then 960 mg daily. Pariticpants continue on study treatment until they meet a protocol defined reason for treatment discontinuation or complete the 72 weeks treatment period.
The specific aims for this continuation application are to: 1. Complete CAMUS, the protocol specified treatment, follow-up and close out activities 2. Prepare the final dataset and 3. Complete planned publications, including final results and other papers based on the final trial dataset.
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