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Completed

NCT Number: NCT00062790

Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

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.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Long Beach, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dutasteride

Drug

Primary outcomes

  1. 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 outcomes

  1. Effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on prostatic tissue content of testosterone.

  2. Changes in serum DHT (dihydrotestosterone) and T (testosterone).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels

Important dates

Study start
2003
Study completion
2005
First posted
Jun 17, 2003
Registry last updated
Sep 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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