Back to resultsEfficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction
Primary Purpose
Erectile Dysfunction
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
WC3036-11F/Alprostadil in Vehicle 2.5%
WC3036-12F/Alprostadil in Vehicle 0.5%
WC3036-13P/Vehicle Only 0.5%
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
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
Sites / Locations
- Warner Chilcott Investigational Study Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Placebo Comparator
Arm Label
WC3036-11F/Alprostadil in Vehicle 2.5%
WC3036-12F/Alprostadil in Vehicle 0.5%
WC3036-13P/Vehicle Only 0.5%
Arm Description
Treatment A
Treatment B
Treatment C
Outcomes
Primary Outcome Measures
Penile rigidity
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Penile rigidity
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Penile rigidity
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Secondary Outcome Measures
Quality of erection
Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.
Quality of erection
Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.
Quality of erection
Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01810575
Brief Title
Efficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Re-assessment of study
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WC3036-11F/Alprostadil in Vehicle 2.5%
Arm Type
Active Comparator
Arm Description
Treatment A
Arm Title
WC3036-12F/Alprostadil in Vehicle 0.5%
Arm Type
Experimental
Arm Description
Treatment B
Arm Title
WC3036-13P/Vehicle Only 0.5%
Arm Type
Placebo Comparator
Arm Description
Treatment C
Intervention Type
Drug
Intervention Name(s)
WC3036-11F/Alprostadil in Vehicle 2.5%
Other Intervention Name(s)
11F
Intervention Description
330 mcg alprostadil in 2.5% vehicle
Intervention Type
Drug
Intervention Name(s)
WC3036-12F/Alprostadil in Vehicle 0.5%
Other Intervention Name(s)
12F
Intervention Description
330 mcg alprostadil in 0.5% vehicle
Intervention Type
Drug
Intervention Name(s)
WC3036-13P/Vehicle Only 0.5%
Other Intervention Name(s)
Vehicle
Intervention Description
100 mg cream vehicle 0.5%.
Primary Outcome Measure Information:
Title
Penile rigidity
Description
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Time Frame
Visit 1 / Up to 5 days ± 3 days
Title
Penile rigidity
Description
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Time Frame
Visit 2 / Up to 9 days ± 3 days
Title
Penile rigidity
Description
≥60% at base and tip of penis lasting for ≥ 5 minutes evaluated with RigiScan. Treatment visits will be separated by at least 2 days.
Time Frame
Visit 3 / Up to 14 Days
Secondary Outcome Measure Information:
Title
Quality of erection
Description
Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.
Time Frame
Visit 1 / Up to 5 days ± 3 days
Title
Quality of erection
Description
Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.
Time Frame
Visit 2 / Up to 9 days ± 3 days
Title
Quality of erection
Description
Subject description of quality of erection using non-validated questionnaire. Treatment visits will be separated by at least 2 days.
Time Frame
Visit 3 / Up to 14 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilma Sniukiene, MD
Organizational Affiliation
Warner Chilcott
Official's Role
Study Director
Facility Information:
Facility Name
Warner Chilcott Investigational Study Site
City
Purchase
State/Province
New York
ZIP/Postal Code
10755
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy & Safety of Single Dose Alprostadil Cream (2 Concentrations Enhancer) to Vehicle in Men w/Erectile Dysfunction
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