Efficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction

August 8, 2014 updated by: Warner Chilcott

A Study to Assess the Relative Efficacy and Safety of a Single Dose of Alprostadil Cream Combined With 2 Concentrations of WC3036 Compared to Vehicle in Subjects With Erectile Dysfunction

The purpose of this study is to assess the safety & efficacy of a single dose of alprostadil cream with 2 concentrations of WC3036 compared to vehicle alone in men with erectile dysfunction.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Purchase, New York, United States, 10755
        • Warner Chilcott Investigational Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male subject aged 40 or older of any race
  • History of ED (erectile dysfunction) of at least 3 months duration defined as inability to attain & maintain an erection of the penis sufficient to permit satisfactory sexual intercourse
  • Completed and signed informed consent prior to any study related procedures

Exclusion Criteria:

  • History/presence any significant disease that Investigator feels will interfere with course of the study
  • Anatomic deformity of penis
  • History/presence alcoholism or drug abuse/dependence within past 2 years (discretion of Investigator)
  • Participation in investigational study drug trial within 30 days prior to randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: WC3036-11F/Alprostadil in Vehicle 2.5%
Treatment A
Drug: WC3036-11F/Alprostadil in Vehicle 2.5%
330 mcg alprostadil in 2.5% vehicle
Other Names:
  • 11F
Experimental: WC3036-12F/Alprostadil in Vehicle 0.5%
Treatment B
Drug: WC3036-12F/Alprostadil in Vehicle 0.5%
330 mcg alprostadil in 0.5% vehicle
Other Names:
  • 12F
Placebo Comparator: WC3036-13P/Vehicle Only 0.5%
Treatment C
Drug: WC3036-13P/Vehicle Only 0.5%
100 mg cream vehicle 0.5%.
Other Names:
  • Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Penile rigidity
Time Frame: Visit 1 / Up to 5 days ± 3 days
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Visit 1 / Up to 5 days ± 3 days
Penile rigidity
Time Frame: Visit 2 / Up to 9 days ± 3 days
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Visit 2 / Up to 9 days ± 3 days
Penile rigidity
Time Frame: Visit 3 / Up to 14 Days
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Visit 3 / Up to 14 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of erection
Time Frame: Visit 1 / Up to 5 days ± 3 days
Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.
Visit 1 / Up to 5 days ± 3 days
Quality of erection
Time Frame: Visit 2 / Up to 9 days ± 3 days
Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.
Visit 2 / Up to 9 days ± 3 days
Quality of erection
Time Frame: Visit 3 / Up to 14 days
Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.
Visit 3 / Up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Warner Chilcott

Investigators

  • Study Director: Vilma Sniukiene, MD, Warner Chilcott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

February 27, 2013

First Submitted That Met QC Criteria

March 11, 2013

First Posted (Estimate)

March 13, 2013

Study Record Updates

Last Update Posted (Estimate)

August 12, 2014

Last Update Submitted That Met QC Criteria

August 8, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR-13311

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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