drugset / Trial / NCT01937871

A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)

NCT01937871 ↗

Phase 3 Completed 909 enrolled Eli Lilly and Company
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to see whether tadalafil can reduce the signs and symptoms in men with Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia-Lower Urinary Tract Symptoms (BPH-LUTS) and improve their quality of life.

Timeline

Start
2013-09
Primary completion
2015-12
Completion
2015-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs 5 mg Tadalafil; Mean Difference (Final Values) -1.41 (95% CI -2.25 to -0.57) NCT01937871 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tadalafil Small molecule 5 mg Oral
Subject Tamsulosin Other / unclassified 0.2 mg Oral