Efficacy, Safety and Satisfaction of VITAROS (Transdermal Topical Alprostadil) in Men With Erectile Dysfunction
Information source: Lawson Health Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Alprostadil (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: Lawson Health Research Institute Official(s) and/or principal investigator(s): Gerald Brock, MD, Principal Investigator, Affiliation: St.Joseph's Health Care
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.
Clinical Details
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.
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores.
Secondary outcome: Evaluate patient satisfaction of transdermal topical alprostadil when compared to patient's most current mode of therapy for erectile dysfunction.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
Locations and Contacts
St. Joseph's Health Care London, London, Ontario N6A 4V2, Canada
Additional Information
Related publications: Costa P, Potempa AJ. Intraurethral alprostadil for erectile dysfunction: a review of the literature. Drugs. 2012 Dec 3;72(17):2243-54. doi: 10.2165/11641380-000000000-00000. Review.
Starting date: December 2013
Last updated: March 3, 2014
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