A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia.

Trial Profile

A Phase 3b, Randomized, Double-blind, Placebo-controlled Parallel-design Study to Evaluate the Efficacy and Safety of Tadalafil Co-administered With Finasteride for 6 Months in Men With Lower Urinary Tract Symptoms and Prostatic Enlargement Secondary to Benign Prostatic Hyperplasia.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jun 2015

At a glance

  • Drugs Tadalafil (Primary) ; Finasteride
  • Indications Benign prostatic hyperplasia; Lower urinary tract symptoms
  • Focus Registrational; Therapeutic Use
  • Sponsors Eli Lilly
  • Most Recent Events

    • 25 Oct 2013 Results from this study have been accepted for publication in the Journal of Urology, according to an Eli Lilly media release.
    • 25 Oct 2013 The US FDA approved a product label addition for Cialis to include data from this 26-week study, according to an Eli Lilly media release.
    • 06 May 2013 Results presented at the 108th Annual Meeting of the American Urological Association.
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