Safety Profile

 

GIOXIL-36 has been administered to over 6550 men in worldwide clinical trials. In trials of GIOXIL-36 for once daily use, a total of 716, 389, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For GIOXIL-36 for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.

  

GIOXIL-36 was generally well tolerated in clinical trials*

 

Cardiovascular safety

Pooled results from 36 controlled and open-label clinical trials are presented in the table below. Doses of GIOXIL-36 ranged from 2 mg to 50 mg, with most patients receiving 20 mg. Patients were excluded from trials if they had an underlying cardiovascular disorder sufficiently severe or unstable to make sexual intercourse inadvisable.

GIOXIL-36 taken as needed n=12,978; GIOXIL-36 taken once daily n=10772

The incidence of serious cardiovascular treatment-emergent adverse events with GIOXIL-36 taken once daily was comparable to placebo§2

One patient with comorbid hypertension and hyperlipidemia who received GIOXIL-36 2.5 mg for once daily use had a nonfatal MI3

 

 
 
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