Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels

Sponsoren

Hauptsponsor: GlaxoSmithKline

Quelle GlaxoSmithKline
Kurze Zusammenfassung

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.

Gesamtstatus Completed
Anfangsdatum October 2003
Fertigstellungstermin July 2005
Phase Phase 4
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
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).
Sekundäres Ergebnis
Messen Zeitfenster
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).
Einschreibung 50
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Dutasteride

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: Male

Mindestalter: 50 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
GSK Clinical Trials Study Director GlaxoSmithKline
Ort
Einrichtung:
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
Standort Länder

United States

Überprüfungsdatum

September 2016

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Patientendaten Yes
Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Double

Quelle: ClinicalTrials.gov