Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia
Intervention: Dutasteride (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: 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 outcome: 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).
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion criteria:
- 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.
Exclusion criteria:
- 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
Locations and Contacts
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, 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
Additional Information
Starting date: October 2003
Last updated: October 1, 2010
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