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A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Urologic Consultants of Southeastern PA
ClinicalTrials.gov Identifier:
NCT00690950
First received: June 3, 2008
Last updated: June 4, 2008
Last verified: June 2008

June 3, 2008
June 4, 2008
May 2008
July 2009   (final data collection date for primary outcome measure)
Laboratory parameters: including serum testosterone, DHT level and PSA [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • volume measurements of TRUSP and PVR [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • A decrease in the AUASI [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Determine the Improvement of the Symptoms of Benign Prostatic Hyperplasia (BPH) When Switching Subjects From Proscar to Avodart
Switch Study: Are There Any Measurable Differences When Switching Patients on Finasteride Therapy to Dutasteride?
Hypothesis: Dutasteride will perform better than finasteride in decreasing prostate volume, improving symptoms based on International Prostate Symptom score,and lower pvr based on the scientific information that dutasteride inhibits both Type I and II 5-alpha-reducatase vs. finasteride which only inhibits the Type II enzyme
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Benign Prostatic Hyperplasia
Drug: Dutasteride
0.5mg capsule, taken once daily for 12 months
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
Not Provided
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male
  • Age 50-80
  • On finasteride for no less than 12 months
  • Willing to undergo all necessary test in the 12 month evaluation

Exclusion Criteria:

  • History of medication non-compliance
  • Unwillingness to undergo/tolerate 2 blood draws
  • Unwillingness to tolerate/undergo 2 TRUSP
Male
50 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00690950
110895
Yes
Not Provided
Not Provided
Dr. Richard C. Harkaway, Urologic consultants of Southeastern PA
Urologic Consultants of Southeastern PA
Not Provided
Not Provided
Urologic Consultants of Southeastern PA
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP