JW a little info for a change.
June 16, 1998
I'm writing to invite you to participate in a multicenter study to evaluate the safety and efficacy of MUSE~ (alprostadil) in patients who have failed prior ViagraTM (sildenafil citrate) therapy for the treatment of erectile dysfunction. As you know, the recent introduction of sildenafil into the U.S. marketplace has dramatically
increased the number of patients seeking treatment for erectile dysfunction. Many of these patients may find sildenafil useful; however, some will discontinue the use of sildenafil and choose other treatment options. The objectives of this study are to provide a better understanding of the patients who discontinue sildenafil and to determine the efficacy and safety of MUSE as a treatment option for these patients.
This study will evaluate approxirnately 1000 patients who are seeking MUSE therapy after they have discontinued the use of sildenafil. Only patients for whom you would ordinarily prescribe MUSE are eligible for this study. The study requires that two forms be completed for each patient, one at the start of MUSE therapy and one after 6-8 weeks of treatment.
We would like each participating investigator to enroll up to 20 patients from his or her clinic. We will provide.a payment in the amount of $50 for each form completed and faxed to VIVUS for a total payment of up to $2000. If you are interested in participating in this study, please provide the information requested on the following page and return it to VIVUS by June 26th Once we receive the attached signature page, we will contact you regarding the details of the study. Should you have any questions, please feel free to call my associates Kerry Nemo at 650-934-5301 or Peter Tam at 650-934-5309.
Sincerely,
Neil Gesundheit, M.D.
Vice President, Clinical Research
VIVUS. inc. 605 East Fairchild Drive, Mountain View, CA 94043 Tei 650-934-5200 Fax 650-934-5389 www.vVus.com
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