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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
History of Changes
  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: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   50 Years to 80 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Richard C. Harkaway, Urologic consultants of Southeastern PA
ClinicalTrials.gov Identifier: NCT00690950     History of Changes
Other Study ID Numbers: 110895
Study First Received: June 3, 2008
Last Updated: June 4, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Urologic Consultants of Southeastern PA:
BPH

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
 Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013