Efficacy, Safety and Satisfaction of VITAROS (Transdermal... | NCT01776320

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

NCT01776320

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Withdrawn

Last Update Posted

Mar 4, 2014Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Erectile Dysfunction

Interventions

Alprostadil

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No medication

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Dec 7, 2012

First Submission Date that Met QC Criteria

Jan 25, 2013

First Posted Date

Jan 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2014

Last Update Posted Date

Mar 4, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gerald Brock, Professor, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VITAROS	Experimental	VITAROS (Alprostadil) 330 ug PRN (as needed) transdermal topical 4-8 weeks	Drug: Alprostadil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Alprostadil	Drug	One unit of Vitaros(330ug of Alprostadil)once a week or once every two weeks for four or eight weeks.	VITAROS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The efficacy of Topical alprostadil in the treatment of erectile dysfunction as measured by IIEF scores.		4 - 8weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gerald Brock, MD	St.Joseph's Health Care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Joseph's Health Care London		London	Ontario	N6A 4V2	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23170913	Background	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.

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological

ID	Term
D011458	Prostaglandins E
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated