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.

First Received: June 3, 2008 Last Updated: June 4, 2008 History of Changes

Sponsor:	Urologic Consultants of Southeastern PA
Information provided by:	Urologic Consultants of Southeastern PA
ClinicalTrials.gov Identifier:	NCT00690950

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment
Official Title:	Switch Study: Are There Any Measurable Differences When Switching Patients on Finasteride Therapy to Dutasteride?

Resource links provided by NLM:

Drug Information available for: Finasteride Dutasteride

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:

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

Keywords provided by Urologic Consultants of Southeastern PA:

BPH

Additional relevant MeSH terms:

Dutasteride
Hyperplasia
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases

Prostatic Hyperplasia
Enzyme Inhibitors
Genital Diseases, Male
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010