Efficacy, Safety and Satisfaction of VITAROS (Transdermal Topical Alprostadil) in Men With Erectile Dysfunction
A Phase 4 clinical trial that is open, with no blinding of subjects or randomization of treatment. Patients with erectile problems will be given the approved drug Vitaros to treat their condition. They will be given forms and questionnaires to complete. The information collected will be used to assess the effectiveness, safety and the satisfaction levels with this drug.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 4, Open-Label, Non-Randomized, Clinical Trial to Evaluate the Efficacy, Safety and Satisfaction of VITAROS (Transdermal Topical Alprostadil) in Men With Erectile Dysfunction.|
- The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores. [ Time Frame: 4 - 8weeks ] [ Designated as safety issue: Yes ]
- Evaluate patient satisfaction of transdermal topical alprostadil when compared to patient's most current mode of therapy for erectile dysfunction. [ Time Frame: 4 - 8 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
VITAROS (Alprostadil) 330 ug PRN (as needed) transdermal topical 4-8 weeks
One unit of Vitaros(330ug of Alprostadil)once a week or once every two weeks for four or eight weeks.
Other Name: VITAROS
Transdermal topical alprostadil has been approved for use in Canada as a treatment for erectile dysfunction. However, as this form of treatment is new, and Canada is the first country in the world to approve its use. There are very few published articles in literature to evaluate its clinical acceptance. By performing a Phase 4, Open-Label, Non-Randomized, Clinical Trial to Evaluate the Efficacy, Safety and Satisfaction of VITAROS (transdermal topical alprostadil) in Men with Erectile Dysfunction, this study can improve understanding of this method of treatment as compared to conventional treatment.
|St. Joseph's Health Care London|
|London, Ontario, Canada, N6A 4V2|
|Principal Investigator:||Gerald Brock, MD||St.Joseph's Health Care|