Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels
Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels
1 other identifier
interventional
50
1 country
11
Brief Summary
This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2003
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2003
CompletedFirst Posted
Study publicly available on registry
June 17, 2003
CompletedStudy Start
First participant enrolled
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2005
CompletedSeptember 15, 2016
September 1, 2016
June 16, 2003
September 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of repeat oral daily dosing of 0.5mg dutasteride compared to placebo on prostate tissue content of DHT in patients treated for 3 months prior to transurethral resection of the prostate (TURP).
Secondary Outcomes (2)
Effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on prostatic tissue content of testosterone.
Changes in serum DHT (dihydrotestosterone) and T (testosterone).
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with benign prostatic hyperplasia
- Must be scheduled to have a transurethral resection of the prostate (prostate surgery) and be able to wait 3 months to have the procedure.
- PSA (prostate specific antigen) level must be between 1.5 and 15 ng/ml.
You may not qualify if:
- Prostate cancer.
- Use of saw palmetto or other over the counter treatments for prostate health chemically related to the study medication.
- Previous finasteride use or other investigational 5ARI within 6 months prior to screening.
- History of chronic UTIs (urinary tract infections)
- Presence of acute bacterial prostatitis at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (11)
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
New Britain, Connecticut, 06052, United States
GSK Investigational Site
Trumbull, Connecticut, 06611, United States
GSK Investigational Site
Augusta, Georgia, 30912, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Niles, Illinois, 60714, United States
GSK Investigational Site
Boston, Massachusetts, 02114-3139, United States
GSK Investigational Site
Lebanon, New Hampshire, 03756, United States
GSK Investigational Site
Eugene, Oregon, 97401-8122, United States
GSK Investigational Site
Dallas, Texas, 75235, United States
GSK Investigational Site
Richmond, Virginia, 23249, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2003
First Posted
June 17, 2003
Study Start
October 1, 2003
Study Completion
July 1, 2005
Last Updated
September 15, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.