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Clinical Trial Information
   
     
 

Viadur (leuprolide acetate implant) is a palliative treatment for advanced prostate cancer that ensures continuous, reliable 12-month leuprolide delivery with a single treatment. In two open-label, multicenter non-comparative studies, 131 patients with prostate cancer were treated with Viadur and evaluated for up to two years.1, 2, 3

Following the initial insertion of the implant, mean serum testosterone concentrations decreased to castrate levels within two to four weeks in 99 percent of the patients in the study. 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 serum testosterone reduction was achieved, there were 0% testosterone breakthroughs for the duration of the 12-month treatment phase.

In clinical trials, the most common systemic side effects reported with Viadur were vasodilation (hot flashes) (67.9 %), gynecomastia (6.9 %) and sweating (5.3 %). Other systemic side effects experienced with Viadur were asthenia (7.6 %) and depression (5.3 %).

Local application site reactions reported by patients after insertion or removal of the implant included bruising (34.6 %) and burning (5.6 %). The majority of local reactions associated with initial insertion or removal and insertion of a new implant began and resolved within the first two weeks. Local reactions persisted in 9.3% of patients; 10.3% of patients developed local reactions 2 weeks after insertion.

 
Details about 0% testosterone breakthroughs once coninuous suppressions was achieved
 
Further details about patient reactions during clinical trials
 

Further details about the clinical trials

 
References

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.