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A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men With Both Erectile Dysfunction and Benign Prostatic Hyperplasia.

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men With Both Erectile Dysfunction and Benign Prostatic Hyperplasia.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Oct 2021

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At a glance

  • Drugs Tadalafil (Primary)
  • Indications Benign prostatic hyperplasia; Erectile dysfunction; Lower urinary tract symptoms
  • Focus Registrational; Therapeutic Use
  • Acronyms COMORBID; LVHR
  • Sponsors Eli Lilly and Company

Most Recent Events

  • 19 Apr 2016 Results of a pooled analysis from four trials (n= 1462) published in the Journal of Urology
  • 24 Aug 2015 Results of post-hoc analysis of pooled data from four trials published in the International Journal of Clinical Practice.
  • 10 Nov 2012 Planned number of patients changed from 501 to 1002 as reported by European Clinical Trials Database record.

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