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