general conditions of use
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© 2007 Bayer HealthCare Pharmaceuticals

 


Physician Support
Clinical Trial Phase III Parameters
   
     
 
Treatment Plan
  Patient Characteristics  
  Treatment History  
  Disease Stage  
   
Treatment Plan Planned Visits
-12 month treatment phase Days 0, 3, 7, 14, 21, 28, 42, 56 then q 4 weeks
- 12 month safety extension

Days 0, 3, 7, 14, 21, 28, 42, 56 then q 3 months

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Patient Characteristics

Parameter Mean (SD) Min, Max
Age (years) 74 (7.9) 50, 88
Weight (kg) 86.8 (14.3) 58, 124
Time since Dx (months) 36.6 (44.6) 0, 203

Race: 75% Caucasian, 22.5% black, 2.5% Hispanic

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Treatment History
No prior treatment 43.8%
Prior treatment
     Radical prostactectomy 11.3%
     Radiation (non-palliative) 18.8%
     Combination therapy

25.2%

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Disease Stage

A 2.5%
B 37.5%
C 38.8%
D1 11.3%
D2

10.0%

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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.