Trial Information

Summary: A study with an experimental drug given each 6 months to help improve difficulty urinating due to an enlarged prostate

An experimental drug will be administered by injection in the buttock to approximately 600 men with difficulty urinating due to an enlarged prostate;

  • During the first year, 3 injections (over 2 weeks) will be administered each 6 months; 1/3 of the participants will receive a placebo (a product with no effect)
  • In the second year, 3 injections (over 2 weeks) will be administered each 6 months; all participants will receive the experimental drug

The total duration of your participation in this study is about 24 months. The effect of the experimental drug will be evaluated mainly by answering questions on urinary symptoms, quality of life and sexual activity.

Inclusion

  • Men, 50 years and above
  • Moderate to severe difficulty in urinating

Exclusion

  • Urgent or prior surgery of the prostate or bladder
  • Any recent or ongoing major cardiovascular condition such as angina, congestive heart failure, serious heart arrhythmia, heart attack (within the last 6 months)
  • Eczema or dermatitis treated during the last 6 months
  • Insulin dependent diabetes
  • Current or recent use of sexual hormones, drugs for BPH or newly started tricyclic antidepressants
  • Urological disease related to diabetes
  • Liver disease, such as hepatitis
  • Any chronic or acute infections

Contact:

Lorne Aaron, MD,
Carol Paris
Urology South Shore Research
304-3234 Taschereau Blvd
Greenfield Park, Canada,
Telephone: 450-671-2945
Email:

 

If you would like to learn more about participating in this study, please send an e-mail message using the form below.

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Trial listings updated: February 25, 2008 at 3:12:41 PM


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