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

Erectile Dysfunction Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01776320
• Other study ID #: 103243
• Status: Withdrawn
• Phase: Phase 4
• First received: December 7, 2012
• Last updated: March 3, 2014
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2014
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

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

Locations

Country	Name	City	State
Canada	St. Joseph's Health Care London	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores.		4 - 8weeks	Yes
Secondary	Evaluate patient satisfaction of transdermal topical alprostadil when compared to patient's most current mode of therapy for erectile dysfunction.		4 - 8 weeks	No