Clinical trial NCT01776320: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Topical Alprostadil
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores.
timeFrame: 4 - 8weeks
Secondary outcomes:
measure: Evaluate patient satisfaction of transdermal topical alprostadil when compared to patient's most current mode of therapy for erectile dysfunction.
timeFrame: 4 - 8 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care London
state: Ontario
Study officials:
affiliation: St.Joseph's Health Care
name: Gerald Brock, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.