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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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2008 by Urologic Consultants of Southeastern PA.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00690950
First Posted: June 5, 2008
Last Update Posted: June 5, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Urologic Consultants of Southeastern PA
  Purpose
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

Condition Intervention Phase
Benign Prostatic Hyperplasia Drug: Dutasteride Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Switch Study: Are There Any Measurable Differences When Switching Patients on Finasteride Therapy to Dutasteride?

Resource links provided by NLM:


Further study details as provided by Urologic Consultants of Southeastern PA:

Primary Outcome Measures:
  • Laboratory parameters: including serum testosterone, DHT level and PSA [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • volume measurements of TRUSP and PVR [ Time Frame: 12 months ]
  • A decrease in the AUASI [ Time Frame: 12 months ]

Estimated Enrollment: 50
Study Start Date: May 2008
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Dutasteride
    0.5mg capsule, taken once daily for 12 months
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690950


Locations
United States, Pennsylvania
Urologic Consultants of Southeastern PA
Bala Cynwyd, Pennsylvania, United States, 19004
Sponsors and Collaborators
Urologic Consultants of Southeastern PA
  More Information

Additional Information:
Responsible Party: Dr. Richard C. Harkaway, Urologic consultants of Southeastern PA
ClinicalTrials.gov Identifier: NCT00690950     History of Changes
Other Study ID Numbers: 110895
First Submitted: June 3, 2008
First Posted: June 5, 2008
Last Update Posted: June 5, 2008
Last Verified: June 2008

Keywords provided by Urologic Consultants of Southeastern PA:
BPH

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Dutasteride
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs