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 on June 3, 2008. Last Updated on 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:	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:

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:	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 February 09, 2012