To: Dauntless who wrote (2774 ) 3/16/1998 11:27:00 PM From: Bruce Rosen Respond to of 7041
I think the link Cacaito provided deserves to be published here: <<THE JOURNAL OF UROLOOY Vol.159, 1214-1216, April Copyright c 1998 by AM~RIcAN UROLOGICAL ASSOCIATION, INC. Printed in l ORAL PHENTOLAMINE AS TREATMENT FOR ERECTILE DYSFUNCTION ARMJN J. BECKER, CHRJSTIAN G. STIEF*, STEP HAN MACHTENS, DIRK SCHULTHEISS, UWE HARTMANN, MICHAEL C. TRUSS ANI) UDO JONAS From the Departrneots of Urology and Clinical Psychology, Medizinsche Hochschule Hannover, Hannover, Germany ABSTRACT Purpose: For most patients with erectile dysfunction oral agents are a preferred treatment option. Oral or buccal phentolamine has been shown to produce full erections in impotent subsets of study populations. We evaluate the efficacy of oral phentolamine. Materials and Methods: After a comprehensive evaluation 44 patients with recent onset (less than 3 years) of erectile dysfunction and a high likelihood of organogenic etiology underwent a prospective, double-blind and placebo controlled trial with oral phentolamine after placebo. Results: After placebo 4 of the 44 patients who reported full erections were excluded from study. Of the 40 patients in the double-blind phase full erections were achieved by 2 of 10 with placebo, and 3 of 10 with 20 rng., 5 of 10 with 40 mg. and 4 of 10 with 60 mg. phentolamine. There were no serious complications observed during the study, and only a single minor side effect occurred in 1 patient after 60 mg. phentolamine. Conclusions: Our results indicate that oral phentolamine may be of benefit for the treatment of erectile dysfunction. Further studies are required to corroborate our findings. KEY WORDS: penile erection, phentolamine Here is the abstract on Phentolamine Ed >> I believe this is from a subset of the Phase II German studies. Zonagen believes that the studies performed by those doctors experienced with ED testing in Germany, produced better results than those performed by less experienced physicians. I believe that Drs Becker, Stief, et al, are among the more experienced doctors. It is important to remember that overall, the Phase II German studies did not show statistical significance, but subsets like the one described here, did. Zonagen learned from this and as Dauntless said, their Phase III studies showed strong statistical significance. If this did appear in the Journal of Urology, perhaps Zonagen is beginning the process of publishing their results in peer reviewed publications. Like Pfizer, up until now, Zonagen has been reluctant to publish detailed information for competitive reasons. As has been stated by both skeptics and believers, the FDA will receive all the available information that it wants and make a decision on both drugs. I read somewhere that before the FDA will approve Viagra, there will most likely be input from the appropriate committee, but such a meeting has not been scheduled. If so, perhaps Viagra won't be approved as soon as some might expect. Any insights by those familiar with FDA protocol?