Clinical Trial: Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose Comparison Study of the Efficacy and Safety of Lonidamine for the Treatment of Symptomatic Benign Prostatic Hyperplasia

Brief Summary: The purpose of this trial is to evaluate the dose response relationship of lonidamine and the primary efficacy endpoint, International Prostate Symptom Score (IPSS), in subjects with symptomatic benign prostatic hyperplasia (BPH).

Detailed Summary:
Sponsor: Threshold Pharmaceuticals

Current Primary Outcome: IPSS

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Maximum urinary flow rate (Qmax)
  • Post-void residual urine volume (PVR)
  • Prostate volume
  • Prostate specific antigen (PSA)


Original Secondary Outcome:

  • Qmax
  • PVR
  • Prostate volume
  • PSA


Information By: Threshold Pharmaceuticals

Dates:
Date Received: October 10, 2005
Date Started: June 2005
Date Completion:
Last Updated: April 28, 2009
Last Verified: April 2009