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Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Udenafil 50 mg
Udenafil 100 mg
Udenafil 150 mg
Placebo Matching 50 mg Udenafil
Placebo Matching 100 mg Udenafil
Placebo Matching 150 mg Udenafil
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has completed Study PR-01209 or PR-01309
  • Continues in a stable monogamous relationship with a consenting female partner who is at least 19 years of age.
  • Partner is not pregnant or lactating

Exclusion Criteria:

  • Symptomatic coronary artery disease, myocardial infarction or cardiac surgical procedure.
  • Cardiac arrhythmias requiring antiarrhythmic treatment
  • Symptomatic congestive heart failure
  • Taking nitrate medication in any form
  • Uncontrolled diabetes (HbA1c ≥ 13%)
  • Hypersensitivity to phosphodiesterase type 5 (PDE-5) inhibitors

Sites / Locations

  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigative Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigative Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigative Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site
  • Warner Chilcott Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Udenafil 50 mg

Udenafil 100 mg

Udenafil 150 mg

Placebo

Arm Description

50 mg Udenafil

100 mg Udenafil

150 mg Udenafil

Placebo Tablets matching Udenafil tablets

Outcomes

Primary Outcome Measures

International Index of Erectile Function (IIEF) score

Secondary Outcome Measures

Changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction

Full Information

First Posted
February 5, 2010
Last Updated
March 30, 2015
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT01065012
Brief Title
Treatment of Erectile Dysfunction - Long Term Safety and Efficacy
Official Title
Open-Label Phase 3 Study to Evaluate the Long-Term Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (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
Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally administered selective inhibitor of PDE-5 for the treatment of subjects with erectile dysfunction (ED).
Detailed Description
Patients completing the double-blind phase will be entered into Study 01409 at the intermediate dose. Up and down dose adjustments will be allowed.

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 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1027 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Udenafil 50 mg
Arm Type
Experimental
Arm Description
50 mg Udenafil
Arm Title
Udenafil 100 mg
Arm Type
Experimental
Arm Description
100 mg Udenafil
Arm Title
Udenafil 150 mg
Arm Type
Experimental
Arm Description
150 mg Udenafil
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Tablets matching Udenafil tablets
Intervention Type
Drug
Intervention Name(s)
Udenafil 50 mg
Other Intervention Name(s)
WC3043
Intervention Description
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Intervention Type
Drug
Intervention Name(s)
Udenafil 100 mg
Other Intervention Name(s)
WC3043
Intervention Description
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Intervention Type
Drug
Intervention Name(s)
Udenafil 150 mg
Other Intervention Name(s)
WC3043
Intervention Description
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Intervention Type
Drug
Intervention Name(s)
Placebo Matching 50 mg Udenafil
Other Intervention Name(s)
Placebo 50 mg
Intervention Description
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Intervention Type
Drug
Intervention Name(s)
Placebo Matching 100 mg Udenafil
Other Intervention Name(s)
Placebo 100 mg
Intervention Description
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Intervention Type
Drug
Intervention Name(s)
Placebo Matching 150 mg Udenafil
Other Intervention Name(s)
Placebo 150 mg
Intervention Description
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Primary Outcome Measure Information:
Title
International Index of Erectile Function (IIEF) score
Time Frame
Assessment will be made after each use of the study drug over a 36 week use period.
Secondary Outcome Measure Information:
Title
Changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction
Time Frame
Assessment will be made after each use of the study drug over a 36 week use period.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has completed Study PR-01209 or PR-01309 Continues in a stable monogamous relationship with a consenting female partner who is at least 19 years of age. Partner is not pregnant or lactating Exclusion Criteria: Symptomatic coronary artery disease, myocardial infarction or cardiac surgical procedure. Cardiac arrhythmias requiring antiarrhythmic treatment Symptomatic congestive heart failure Taking nitrate medication in any form Uncontrolled diabetes (HbA1c ≥ 13%) Hypersensitivity to phosphodiesterase type 5 (PDE-5) inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herman Ellman, MD
Organizational Affiliation
Warner Chilcott
Official's Role
Study Director
Facility Information:
Facility Name
Warner Chilcott Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Warner Chilcott Investigative Site
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Warner Chilcott Investigative Site
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Dawsonville
State/Province
Georgia
ZIP/Postal Code
30534
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Greenwood
State/Province
Indiana
ZIP/Postal Code
46143
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Harrisburg
State/Province
North Carolina
ZIP/Postal Code
28075
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Warner Chilcott Investigative Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76017
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

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