At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 618 enrolled
Drug / intervention
Udenafil +1 moredrug
Likely dose
Not stated in 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.
Randomized, Placebo-controlled, Double-Blind, Parallel Design, Phase 3 Study to Assess the Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction
In Brief
A Phase 3 clinical trial evaluating Udenafil and Placebo for Erectile Dysfunction. Completed, enrolled 618 participants across 36 sites.
Detailed Summary
Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErectile Dysfunction
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2009
First PostedDec 2009
Primary CompletionMar 2010
TodayJul 2026
First PostedDec 22, 2009
Enrollment StartSep 1, 2009
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.5 years ago
Interventions
Udenafildrug
Tablets via oral administration before an attempt at sexual intercourse.
Placebodrug
Tablets via oral administration before an attempt at sexual intercourse.