Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

Phase 4

Completed

• Conditions: Prostatic Hyperplasia

• Registration Number: NCT00062790
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-06-16
• Study First Submitted QC: 2003-06-16
• Study First Posted: 2003-06-17
• Study Start: 2003-10
• Study Completion: 2005-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Changes in serum DHT (dihydrotestosterone) and T (testosterone).
Effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on prostatic tissue content of testosterone.

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Richmond, Virginia, United States