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Clinical Trial Phase III Results		    
     
 

Produced a clinically significant decrease in serum PSA concentrations:

Serum PSA decreased in all patients after insertion. At six months PSA concentration decreased from baseline by at least 90 percent in 74.2 percent of the 97 evaluable patients.
  Androgen reduction success rate was 99 percent.  
  Testosterone was below the castrate threshold between weeks two and four in all but one patient, following the expected initial increase. Continuous androgen reduction in this patient occurred at week 28.  
  Once reduced, testosterone remained well below the castrate threshold for the duration of treatment.  
  Reduction was maintained following removal of the existing implant and insertion of a new implant, with no rise in testosterone.  
 
Further details about the 99% reduction success rate
 
Further details about patient reactions during clinical trials
 
Further details about the clinical trials

 

Important Safety Considerations
Viadur is contraindicated in patients with hypersensitivity to Gn-RH, Gn-RH agonist analogs, or any of the components in Viadur.

Viadur is contraindicated in women and pediatric patients and was not studied in women or children.

Viadur, like other LH-RH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. Patients may experience a worsening of symptoms or onset of new symptoms including bone pain, neuropathy, hematuria, or ureteral or bladder outlet obstruction, and spinal cord compression.

The most comment systemic side effects were hot flashes (67.9%), asthenia (7.6%), gynecomastia (6.9%), depression (5.3%), and sweating (5.3%). The most common local side effects were bruising (34.6%) and burning (5.6%).

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© Copyright 2007 Bayer HealthCare Pharmaceuticals. Viadur is a trademark of ALZA Corporation under license to Bayer HealthCare Pharmaceuticals. DUROS® is a registered trademark of ALZA Corporation.

The information provided on Bayer products is only intended for the United States audience. Regulatory requirements, regulations, laws, and distribution of information about drug products may vary from country to country. Product names and indications (product uses) also may be different in different countries. The prescribing information provided here is based on United States labeling and may not be appropriate outside of the United States.