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

June 4, 2008 updated by: Urologic Consultants of Southeastern PA

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Urologic Consultants of Southeastern PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Laboratory parameters: including serum testosterone, DHT level and PSA
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
volume measurements of TRUSP and PVR
Time Frame: 12 months
12 months
A decrease in the AUASI
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Urologic Consultants of Southeastern PA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Estimate)

June 5, 2008

Last Update Submitted That Met QC Criteria

June 4, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 110895

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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