At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 217 enrolled
Drug / intervention
tadalafil +1 moredrug
Likely dose
tadalafil 5 milligramsfrom 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.
A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Efficacy and Safety of Tadalafil (LY450190) Once a Day in Subjects With Erectile Dysfunction Who Are Naïve to PDE5 Inhibitors
In Brief
A Phase 3 clinical trial evaluating tadalafil and placebo for Erectile Dysfunction. Completed, enrolled 217 participants across 21 sites in 5 countries.
Detailed Summary
The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErectile Dysfunction
CountriesGermany, Greece, Italy, Poland, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2009
First PostedFeb 2009
Primary CompletionJan 2010
TodayJul 2026
First PostedFeb 4, 2009
Enrollment StartJan 1, 2009
Primary CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 17.4 years ago
Interventions
tadalafildrug
5 milligrams (mg) administered orally once a day for 12 weeks
placebodrug
tablet administered orally once a day for 12 weeks.