Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

Overview

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.

Full Title of Study: “Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double

Interventions

  • Drug: Dutasteride

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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).

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GlaxoSmithKline
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GSK Clinical Trials, Study Director, GlaxoSmithKline

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