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

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ClinicalTrials.gov Identifier: NCT01776320
Recruitment Status : Withdrawn (No medication)
First Posted : January 28, 2013
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
Gerald Brock, Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Alprostadil Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : December 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil
U.S. FDA Resources

Arm Intervention/treatment
Experimental: VITAROS
VITAROS (Alprostadil) 330 ug PRN (as needed) transdermal topical 4-8 weeks
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



Primary Outcome Measures :
  1. The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores. [ Time Frame: 4 - 8weeks ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776320


Locations
Canada, Ontario
St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Gerald Brock, MD St.Joseph's Health Care

Publications:
Responsible Party: Gerald Brock, Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01776320     History of Changes
Other Study ID Numbers: 103243
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014

Keywords provided by Gerald Brock, Lawson Health Research Institute:
Erectile Dysfunction
Topical Alprostadil

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Alprostadil
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents