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Biotech / Medical : Zonagen (zona) - good buy?
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To: Hank who wrote (3792)5/2/1998 11:13:00 AM
From: Linda Kaplan  Read Replies (1) of 7041
 
Here's the text of the poster on Vasomax. A few characters were smudged so there may be an error in one or two characters:

EFFICACY AND SAFETY OF ORAL PHENTOLAMINE (VASOMAX) FOR THE TREATMENT OF MINIMAL
ERICTILE DYSFUNCTION Irwin Goldstein and the Vasomax Study Group, Boston, MA, Presented by Dr. Goldstein

INTRODUCTION AND OBJECTIVES: This study reports the results of the first double-blinded, placebo-controlled
studiesevaluating the efficacy and safety of oral phentalomine in the treatment of patients with minimal erectile dysfunction
of broad specturm etiology.

METHODS: Tso multi-center trials were conducted in the United States in men with minimal erectile dysfunction. The
first was designed as a placebo controlled, parallel group, double-blind study involving randomized doses of 40 or 80 mg
of oral phentolamine or placebo. The second was a placebo-controlled crossover design trial of fixed dose 40 mg oral
phentolamine vs. placebo. A responder was considered any patient whose endpoint International Index of Erectile
Function domain score improved by at least one clinical dysfunction class and who meets the criteria at least for
mid-to-moderate dysfunction at endpoint.

RESULTS:
Study No.
Treatment Group n %of Responders %of Non-Responders
ZON 301
Placebo 148 16 84
40 mg Vasomax 152 37 63
80 mg Vasomax 159 45 55
p<0.001 (CMH, controlling for investigator)
ZON 300 (first period crossover)
Placebo 145 21* 79
40 mg Vasomax 148 34* 64
p<0.009 (CMH, controlling for investigator)
*Includes all ITT patients with non-missing data
There were no serious adverse events. Side effects to the 40 mg phentolamine(<10% occurrence)included headaches,
facial flushing, nasal congestion.
CONCLUSIONS: Oral phentolamine (40mg) is a safe and effective oral medication for the treatment of mild erectile
dysfunction.
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