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Trial record 53 of 117 for:    DUTASTERIDE

A Clinical Trial Comparing Laser TURP With and Without Dutasteride.

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.
 
ClinicalTrials.gov Identifier: NCT00431626
Recruitment Status : Terminated (Low enrollment)
First Posted : February 6, 2007
Results First Posted : January 1, 2015
Last Update Posted : October 28, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Kevin McVary, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Benign Prostatic Hyperplasia
Interventions Drug: Dutasteride (Avodart)
Drug: Placebo
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 4 0
Completed 4 0
Not Completed 0 0
Arm/Group Title Laser TURP With Dutasteride Laser TURP With Placebo Total
Hide Arm/Group Description

Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient

Dutasteride (Avodart)

Prior to and after standard treatment with laser TURP, placebo is applied to each patient Total of all reporting groups
Overall Number of Baseline Participants 4 0 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 0 participants 4 participants
47  (12) 47  (12)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 0 participants 4 participants
Female 0 0
Male 4 4
1.Primary Outcome
Title Primary Outcome Measure Will be the 5 Point Change in AUA Symptom Index
Hide Description AUA symptoms index change is measured on a five level-scale: -2 (much worse), -1(worse) , 0 (no change), 1 (better), 2 (much better)
Time Frame one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laser TURP With Dutasteride Laser TURP With Placebo
Hide Arm/Group Description:

Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient

Dutasteride (Avodart)

Prior to and after standard treatment with laser TURP, placebo is applied to each patient
Overall Number of Participants Analyzed 4 0
Mean (Standard Deviation)
Unit of Measure: units on a scale
1  (0.8)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Laser TURP With Dutasteride Laser TURP With Placebo
Hide Arm/Group Description

Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient

Dutasteride (Avodart)

Prior to and after standard treatment with laser TURP, placebo is applied to each patient
All-Cause Mortality
Laser TURP With Dutasteride Laser TURP With Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Laser TURP With Dutasteride Laser TURP With Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Laser TURP With Dutasteride Laser TURP With Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/0 
Difficulty in recruitment forced the closing of this trial.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Borko D. Jovanovic, MS, PhD
Organization: Northwestern U
Phone: 312 503 2008
EMail: borko@northwestern.edu
Layout table for additonal information
Responsible Party: Kevin McVary, Northwestern University
ClinicalTrials.gov Identifier: NCT00431626     History of Changes
Other Study ID Numbers: 0348-040
First Submitted: February 2, 2007
First Posted: February 6, 2007
Results First Submitted: December 19, 2014
Results First Posted: January 1, 2015
Last Update Posted: October 28, 2015