Efficacy, Safety and Satisfaction of VITAROS (Transdermal Topical Alprostadil) in Men With Erectile Dysfunction

This study has been withdrawn prior to enrollment.
(No medication)
Sponsor:
Information provided by (Responsible Party):
Gerald Brock, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01776320
First received: December 7, 2012
Last updated: March 3, 2014
Last verified: March 2014

December 7, 2012
March 3, 2014
December 2013
December 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01776320 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Efficacy, Safety and Satisfaction of VITAROS (Transdermal Topical Alprostadil) in Men With Erectile Dysfunction
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.

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.

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.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Erectile Dysfunction
Drug: Alprostadil
One unit of Vitaros(330ug of Alprostadil)once a week or once every two weeks for four or eight weeks.
Other Name: VITAROS
Experimental: VITAROS
VITAROS (Alprostadil) 330 ug PRN (as needed) transdermal topical 4-8 weeks
Intervention: Drug: Alprostadil
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01776320
103243
No
Gerald Brock, Lawson Health Research Institute
Lawson Health Research Institute
Not Provided
Principal Investigator: Gerald Brock, MD St.Joseph's Health Care
Lawson Health Research Institute
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP