A Study in Benign Prostatic Hyperplasia

Phase 3 Completed 97 enrolled Eli Lilly and Company

RandomizedParallel-groupTriple-blindBasic science

Summary

The purpose of this trial is to evaluate the effect of tadalafil 5 milligrams (mg) daily for 8 weeks compared to placebo on prostatic blood perfusion in men with signs and symptoms of Benign Prostatic Hyperplasia (BPH), measured by resistive index (RI) in the prostate transition zone.

Timeline

Start: 2010-09
Primary completion: 2012-07
Completion: 2012-07

Outcome

Missed primary endpoint

paper The overall treatment effect (tadalafil vs placebo) for the change from baseline through week 8 in prostate TZ RI was not statistically significant PMID 24938580 ↗

registry p = 0.121; Difference in LS Means 0.01 NCT01152190 ↗

Publications

Pinggera GM, Frauscher F, Paduch DA, Bolyakov A, Efros M, Kaminetsky J, Da Pozzo L, Esler A, Cox D. Effect of tadalafil once daily on prostate blood flow and perfusion in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: a randomized, double-blind, multicenter, placebo-controlled trial. Urology. 2014 Aug;84(2):412-9. doi: 10.1016/j.urology.2014.02.063. Epub 2014 Jun 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tadalafil	Small molecule	5 mg	Oral