drugset / Trial / NCT01352507

A Study of Tadalafil and Sildenafil in Men With Erectile Dysfunction in China

NCT01352507 ↗

Phase 4 Completed 383 enrolled Eli Lilly and Company
RandomizedCrossoverOpen-labelTreatment

Summary

The primary objective of this study is to evaluate whether, after two 8-week treatment periods, male patients with erectile dysfunction (ED) in China prefer 20 milligram (mg) tadalafil or 100 mg sildenafil. This trial consists of two treatment periods of 8 weeks each and an extension phase of 8 weeks, for a total of 24 weeks.

Timeline

Start
2011-06
Primary completion
2012-06
Completion
2012-07

Outcome

Met primary endpoint

registry NUMBER All Randomized Participants: 69.1 (64 to 74) percentage of participants NCT01352507 ↗

registry analysis (superiority or other test); All Randomized Participants; p <0.001; Wilson Score method NCT01352507 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sildenafil Unknown 100 mg Oral
Subject Tadalafil Small molecule 20 mg Oral

Indications