CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 378 enrolled
Drug / intervention
tadalafil once a day [T(OaD)] +2 moredrug
Likely dose
tadalafil once a day [T(OaD)] 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00734604
NCT00734604Phase 3Completed
CompareCT.gov

A Comparison of Psychosocial Outcomes Following Tadalafil Once a Day or PDE5 Inhibitor As Needed in Men With Erectile Dysfunction.

Eli Lilly and Company·interventional·Posted Aug 14, 2008·Updated Nov 18, 2010

In Brief

A Phase 3 clinical trial evaluating tadalafil once a day [T(OaD)], sildenafil citrate as needed [S(PRN)], and 1 other intervention for Erectile Dysfunction. Completed, enrolled 378 participants across 37 sites in 9 countries.

Detailed Summary

The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErectile Dysfunction
CountriesAustralia, Brazil, Germany, Italy, Mexico, Puerto Rico, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 14, 2008
Enrollment StartAug 1, 2008
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.9 years ago

Interventions

tadalafil once a day [T(OaD)]drug

5 mg tablet taken once a day (OaD) by mouth for 8 weeks

sildenafil citrate as needed [S(PRN)]drug

100 mg tablet taken as needed (PRN) by mouth for 8 weeks

tadalafil as needed [T(PRN)]drug

20 mg tablet taken as needed (PRN) by mouth for 8 weeks