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

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01776320

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

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 :

Dec 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

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 Names: VITAROS

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 Names:

VITAROS

Outcome Measures

Primary Outcome Measures

The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores. [4 - 8weeks]

Secondary Outcome Measures

Evaluate patient satisfaction of transdermal topical alprostadil when compared to patient's most current mode of therapy for erectile dysfunction. [4 - 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

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.

Responsible Party:

Gerald Brock, Professor, Lawson Health Research Institute

ClinicalTrials.gov Identifier:

NCT01776320

Other Study ID Numbers:

103243

First Posted:

Jan 28, 2013

Last Update Posted:

Mar 4, 2014

Last Verified:

Mar 1, 2014

Keywords provided by Gerald Brock, Professor, Lawson Health Research Institute

Erectile Dysfunction

Topical Alprostadil

Additional relevant MeSH terms:

Erectile Dysfunction

Alprostadil

Study Results

No Results Posted as of Mar 4, 2014