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Physician Support
Further Information About Clinical Trials		    
     
 

Phase I/II study:

51 patients at nine sites, two-year treatment duration.
  Completed June 1999.  

Phase III study

80 patients at 19 sites, two-year treatment duration.
  Completed February, 2000.  

Goals:

To demonstrate the efficacy of Viadur through the reduction of testosterone to below the castrate threshold (<50 ng/dl) in patients with advanced prostate cancer eligible for hormonal ablation therapy.
  To evaluate local and systemic adverse effects.  
  To evaluate general and disease-specific quality of life.  

For more information:

Clinical Trial Phase III Parameters
  Clinical Trial Phase III Results  
 
Further details about the 99% reduction success rate
 
Further details about patient reactions during clinical trials
 
Further details about the clinical trials
 
Clinical Trial Phase III Parameters
 
Clinical Trial Phase III Results

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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Bayer HealthCare Pharmaceuticals
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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.