This proposal is one of 12, one for each of the 11 clinical centers plus one for the Data Coordinating Center (DCC), relevant to the continued funding of NIDDK's CAMUS clinical trial that is investigating the efficacy and safety of an extract of the berries of Serenoa repens (saw palmetto) for the treatment of benign prostrate hyperplasia (BPH). Each of the 12 proposals includes a common section prepared under the purview of the study's Steering Committee, followed by a section specific to the center submitting the application. This specific application is for the Clinical Center at the Queen's University at Kingston, Ontario Canada. Details for this center begin on page following the common section below. The overall CAMUS trial (Complementary and Alternative Medicine for Urological Symptoms) is fully functional and well underway. Funded jointly by NIDDK, the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements (ODS), 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 recruited 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 October, 2010. As a consequence, funding is requested for an additional period to permit ail CAMUS subjects to complete the 72 weeks of follow-up specified in the protocol and to allow for appropriate data clean up, analyses and publications. CAMUS is a randomized, double-blind, two arm trial with 369 participants, approximately equally allocated to either the Serenoa repens extract or placebo in escalating doses over three consecutive 24 weeks periods, beginning with 320 mg, then 640 mg, then and then 960 mg daily. Participants continue on study treatment until they meet a protocol defined reason for treatment discontinuation or complete the 72 week treatment period. The 11 CAMUS clinical centers initiated recruitment June 5, 2008 and successfully completed randomization of 369 subjects on April 17, 2009.
Statement not given.
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