A Study in Patients With Erectile Dysfunction

Phase 4 Completed 770 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.

Timeline

Start: 2010-05
Primary completion: 2011-06
Completion: 2011-06

Outcome

Met primary endpoint

registry Tadalafil Once a Day vs Sildenafil Citrate On Demand; p <0.001; Cox Proportional Hazard 0.66 (97.3% CI 0.51 to 0.85) NCT01122264 ↗

registry Tadalafil On Demand vs Sildenafil Citrate On Demand; p <0.001; Cox Proportional Hazard 0.49 (97.3% CI 0.37 to 0.65) NCT01122264 ↗

registry Tadalafil On Demand vs Tadalafil Once a Day; p = 0.033; Cox Proportional Hazard 1.32 (95% CI 1.02 to 1.71) NCT01122264 ↗

Publications

Buvat J, Buttner H, Hatzimouratidis K, Vendeira PA, Moncada I, Boehmer M, Henneges C, Boess FG. Adherence to initial PDE-5 inhibitor treatment: randomized open-label study comparing tadalafil once a day, tadalafil on demand, and sildenafil on demand in patients with erectile dysfunction. J Sex Med. 2013 Jun;10(6):1592-602. doi: 10.1111/jsm.12130. Epub 2013 Apr 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Sildenafil	Unknown	25 mg	Oral
Comparator	Sildenafil	Unknown	50 mg	Oral
Comparator	Sildenafil	Unknown	100 mg	Oral
Subject	Tadalafil	Small molecule	2.5 mg	Oral
Subject	Tadalafil	Small molecule	5 mg	Oral
Subject	Tadalafil	Small molecule	10 mg	Oral
Subject	Tadalafil	Small molecule	20 mg	Oral