A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms

Phase 3 Completed 696 enrolled Eli Lilly and Company

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to investigate the efficacy and safety of once daily tadalafil when taken with finasteride as a treatment for men with signs and symptoms of Benign Prostatic Hyperplasia and demonstrable prostate enlargement.

Timeline

Start: 2010-09
Primary completion: 2012-02
Completion: 2012-05

Outcome

Met primary endpoint

registry analysis (superiority or other test); Tadalafil vs Placebo; p = 0.001; LS Mean Difference -1.41 (95% CI -2.27 to -0.55); Mixed Model Repeated Measures Analysis NCT01139762 ↗

release “Cialis/finasteride met the primary endpoint, significantly improving IPSS total scores through 12 weeks versus placebo/finasteride” lilly.com ↗

Publications

Glina S, Roehrborn CG, Esen A, Plekhanov A, Sorsaburu S, Henneges C, Buttner H, Viktrup L. Sexual function in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia: results of a 6-month, randomized, double-blind, placebo-controlled study of tadalafil coadministered with finasteride. J Sex Med. 2015 Jan;12(1):129-38. doi: 10.1111/jsm.12714. Epub 2014 Oct 29.

Drugs

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