Erectile Dysfunction
Conditions
Keywords
Erectile Dysfunction, Topical Alprostadil
Brief summary
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.
Detailed description
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.
Interventions
DRUGAlprostadil
One unit of Vitaros(330ug of Alprostadil)once a week or once every two weeks for four or eight weeks.
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18y rs old and above * Has mild-to-moderate erectile dysfunction * Currently or previous treated for erectile dysfunction using PDE5 inhibitors, vacuum erection devices (VED), intra-cavernosal injections (ICI) and medical urethral system for erection (MUSE). * Sexually active * Has a regular sexual partner
Exclusion criteria
* Known allergy to alprostadil * Unable to provide own informed consent * Unable to understand and complete a questionnaire in English * Unable to return for a post-treatment clinic evaluation * Regular sexual partner is unable to understand and complete a questionnaire in English * Sexual partner is a pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores. | 4 - 8weeks |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate patient satisfaction of transdermal topical alprostadil when compared to patient's most current mode of therapy for erectile dysfunction. | 4 - 8 weeks |
Countries
Canada
Outcome results
None listed