Treatment of Erectile Dysfunction - Long Term Safety and Efficacy
Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally administered selective inhibitor of PDE-5 for the treatment of subjects with erectile dysfunction (ED).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label Phase 3 Study to Evaluate the Long-Term Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction|
- International Index of Erectile Function (IIEF) score [ Time Frame: Assessment will be made after each use of the study drug over a 36 week use period. ] [ Designated as safety issue: No ]
- Changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction [ Time Frame: Assessment will be made after each use of the study drug over a 36 week use period. ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Subjects initially assigned to 100 mg dose but may titrate down to 50 mg or up to 150 mg as determined by subject and Investigator.
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Patients completing the double-blind phase will be entered into Study 01409 at the intermediate dose. Up and down dose adjustments will be allowed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065012
Show 72 Study Locations
|Study Director:||Herman Ellman, MD||Warner Chilcott|