During this period the study protocol will be active and patients will be completeting their final study visits. Dr. Michael Naslund, PI and Research Coordinator will be seeing the patients for their study visits as well as keeping all regulatory documents in the study current. Additionally the RC will see that all needed lab work and EKGs for patients are conducted at each visit and that patients are adhering to study protocol and are continuing to be compliant to their study medication. The PI and RC will also be making sure that patient retention remains high. We will contact all patients between visits and continue to remind them of any upcoming appointments they have with our office. Dr. Naslund who serves on the CAMUS recruitment and retention board as well as the Steering committee will continue his duties by participating in numerous conference calls and any Steering Committee in person meetings. The RC will also attend coordinator conference calls and study meetings. After the final patient completes his last in office (end of study) visit, we will work with the Data Coordinating Center to complete as well as edit all necessary data to close out the study.
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 NlDDK's CAMUS clinical trial that is investigating the efficacy and safety of an extract of the berries of Serenoa repens (the saw palmetto plant) for the treatment of benign prostrate hyperplasia (BPH).
