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

Information source: Lawson Health Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Erectile Dysfunction

Intervention: Alprostadil (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Lawson Health Research Institute

Official(s) and/or principal investigator(s):
Gerald Brock, MD, Principal Investigator, Affiliation: St.Joseph's Health Care

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.

Clinical Details

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

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

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

St. Joseph's Health Care London, London, Ontario N6A 4V2, Canada
Additional Information

Related 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.

Starting date: December 2013
Last updated: March 3, 2014

Page last updated: August 23, 2015

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