The only side effect noted by the researchers in this study occurred in the group taking the 40 mg dose. One man reported a stuffy nose. Based on the results of this study, the scientists concluded that a 40 mg dose of Vasomax, in a fast-dissolving tablet, appeared to be an optimally safe and efficient medication for men over fifty.
Phase III trials of Vasomax began immediately in Mexico and were completed by the fall. The study included 148 men at seven centers throughout the country. Men with psychological problems were eliminated but men with primary physical causes of ED were allowed in the study. More than 20 percent of the men had diabetes while 10 percent had undergone prostate surgery. Vasomax showed a 50 percent to 60 percent positive response rate with the men.
In November 1996 additional Phase III studies were conducted over twenty centers in the United States with 435 men. Men who were receiving cardiovascular therapy as well as those with diabetes were included in the study. They also had to have had a history of ED for at least six months. Men who had radical prostatectomies and spinal cord injures were intentionally excluded from these trials. This double-blind placebo controlled study showed definite statistical improvement.Men taking the 10 mg Vasomax pill had a 40 percent success rate versus the 17 percent improvement achieved by men taking a placebo. What this dala tells us,” said Raymond Rosen, Ph.D., who reviewed the preliminary data of the Phase III trials and presented his findings at an ED conference in Los Angeles in September 1997, “is that this drug shows definite efficacy in patients with mild to moderate disease, but no efficacy at all for patients with severe ED.”
An interesting finding from these studies was that there appeared to be a pronounced race-related improvement in ED. Black men who took 60 mg of Vasomax had a 60 percent improvement at this dose. “Whether this represents something clinically significant,” said Dr. Rosen, “or whether blacks are particularly responsive to the drug, is too early to tell.”
Dr. Rosen was encouraged by the Vasomax findings. “If you’re looking for an on-demand erectogenic agent, Vasomax is close to the perfect formula,” he says. “The drug is well tolerated, and with the exception of a stuffy nose, there are no noticeable side effects.”
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