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

Primary Purpose

Erectile Dysfunction

Status

Withdrawn

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Alprostadil

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Topical Alprostadil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

St. Joseph's Health Care London

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VITAROS

Arm Description

VITAROS (Alprostadil) 330 ug PRN (as needed) transdermal topical 4-8 weeks

Outcomes

Primary Outcome Measures

The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores.

Secondary Outcome Measures

Evaluate patient satisfaction of transdermal topical alprostadil when compared to patient's most current mode of therapy for erectile dysfunction.

Full Information

NCT ID

NCT01776320

First Posted

December 7, 2012

Last Updated

March 3, 2014

Sponsor

Lawson Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01776320

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Withdrawn

Why Stopped

No medication

Study Start Date

December 2013 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Lawson Health Research Institute

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

Erectile Dysfunction, Topical Alprostadil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VITAROS

Arm Type

Experimental

Arm Description

VITAROS (Alprostadil) 330 ug PRN (as needed) transdermal topical 4-8 weeks

Intervention Type

Drug

Intervention Name(s)

Alprostadil

Other Intervention Name(s)

VITAROS

Intervention Description

One unit of Vitaros(330ug of Alprostadil)once a week or once every two weeks for four or eight weeks.

Primary Outcome Measure Information:

Title

The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores.

Time Frame

4 - 8weeks

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerald Brock, MD

Organizational Affiliation

St.Joseph's Health Care

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Joseph's Health Care London

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

23170913

Citation

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.

Results Reference

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

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