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| Sponsored by: |
GlaxoSmithKline |
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00062790 |
Purpose
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.
| Condition | Intervention | Phase |
|
Benign Prostatic Hyperplasia |
Drug: Dutasteride |
Phase IV |
| Drug Information available for: | Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Dutasteride Stanolone |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacokinetics/Dynamics Study |
| Official Title: | Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels |
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2003 |
Eligibility
| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| United States, California | |||||
| GSK Investigational Site | |||||
| Long Beach, California, United States, 90806 | |||||
| United States, Connecticut | |||||
| GSK Investigational Site | |||||
| New Britain, Connecticut, United States, 06052 | |||||
| GSK Investigational Site | |||||
| Trumbull, Connecticut, United States, 06611 | |||||
| United States, Georgia | |||||
| GSK Investigational Site | |||||
| Augusta, Georgia, United States, 30912 | |||||
| United States, Illinois | |||||
| GSK Investigational Site | |||||
| Niles, Illinois, United States, 60714 | |||||
| GSK Investigational Site | |||||
| Chicago, Illinois, United States, 60612 | |||||
| United States, New Hampshire | |||||
| GSK Investigational Site | |||||
| Lebanon, New Hampshire, United States, 03756 | |||||
| United States, Oregon | |||||
| GSK Investigational Site | |||||
| Eugene, Oregon, United States, 97401-8122 | |||||
| United States, Texas | |||||
| GSK Investigational Site | |||||
| Dallas, Texas, United States, 75235 | |||||
| United States, Virginia | |||||
| GSK Investigational Site | |||||
| Richmond, Virginia, United States, 23249 | |||||
| GlaxoSmithKline |
| Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | ARI40014 |
| First Received: | June 16, 2003 |
| Last Updated: | October 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00062790 |
| Health Authority: | United States: Food and Drug Administration |
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