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Treatment of Erectile Dysfunction II

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Udenafil
Placebo
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:

  • Male, at least 19 years of age
  • Stable monogamous relationship for at least 6 months with a consenting female partner who is at least 19 years of age, vaginal intercourse is a required study activity
  • History of ED (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration
  • Partner is not pregnant or lactating

Exclusion Criteria:

  • History of new-onset symptomatic coronary artery disease within the last 3 months or a history of myocardial infarction or cardiac surgical procedure within six months
  • 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 such as Viagra®, Cialis® or Levitra®
  • Previously failed to respond to PDE-5 inhibitors such as Viagra®, Cialis® or Levitra®

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 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

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 150mg

Placebo

Arm Description

50 mg Udenafil tablet plus 100 & 150 mg placebo tablets

100 mg Udenafil tablet plus 50 & 150 mg placebo tablets

150 mg Udenafil tablet plus 50 & 100 mg placebo tablets

50, 100 & 150 mg placebo tablets

Outcomes

Primary Outcome Measures

Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)
Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection?
Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT
Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT
Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.

Secondary Outcome Measures

Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?
Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Orgasmic Function domain: 0/poor - 5/good scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)?
Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Sexual Desire domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire?
Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Overall Satisfaction domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner?
Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population
While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders)
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT
EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use ? How satisfied w/how quickly it works? How long it lasts? How confident has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?
Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity
Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT
SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT
SEP Question 4: Were you satisfied with the hardness of your erection? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT
SEP Question 5: Were you satisfied with this overall sexual experience? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.

Full Information

First Posted
October 19, 2009
Last Updated
May 20, 2015
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT01037218
Brief Title
Treatment of Erectile Dysfunction II
Official Title
Randomized, Placebo-controlled, Double-Blind, Parallel Design, Phase 3 Study to Assess the Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (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
Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).
Detailed Description
Multi-center, randomized, double-blind, placebo-controlled, parallel-group design, Phase 3 pivotal study to investigate the efficacay and safety of 50 mg, 100 mg and 150 mg udenafil tablets compared with placebo in men with ED. This study consisted of a 4-week, treatment free run-in period followed by a treatment period of 12 weeks, with an on-demand dosing regimen.

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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
601 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Udenafil 50 mg
Arm Type
Experimental
Arm Description
50 mg Udenafil tablet plus 100 & 150 mg placebo tablets
Arm Title
Udenafil 100 mg
Arm Type
Experimental
Arm Description
100 mg Udenafil tablet plus 50 & 150 mg placebo tablets
Arm Title
Udenafil 150mg
Arm Type
Experimental
Arm Description
150 mg Udenafil tablet plus 50 & 100 mg placebo tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
50, 100 & 150 mg placebo tablets
Intervention Type
Drug
Intervention Name(s)
Udenafil
Intervention Description
Tablets via oral administration before an attempt at sexual intercourse.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets via oral administration before an attempt at sexual intercourse.
Primary Outcome Measure Information:
Title
Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward)
Description
Erectile Function domain: 0 - 5 scoring scale for each of 6 questions (scale: 0/min/poor - 30/max/good). Over last month: How often were you able to get erection? When you had erections with stimulation, how often were your erections hard enough for penetration? When you attempted intercourse, how often were you able to penetrate your partner? How often were you able to maintain your erection after penetrating your partner? How difficult was it to maintain your erection to completion of intercourse? How do you rate your confidence that you can get & keep your erection?
Time Frame
Baseline and Week 12
Title
Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT
Description
Question 2 SEP: Were you able to insert your penis into your partner's vagina? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Time Frame
Baseline and Weeks 1-12
Title
Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT
Description
Question 3 SEP: Did your erection last long enough for you to have successful completion of intercourse? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Time Frame
Baseline and Weeks 1-12
Secondary Outcome Measure Information:
Title
Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Description
Satisfaction of Intercourse domain: 0 (poor) - 5/(good) scoring scale for each of 3 questions (0-15/good). Over last month: How many times have you attempted sexual intercourse? When you attempted intercourse, how often was it satisfactory for you? How much have you enjoyed sexual intercourse?
Time Frame
Baseline and Week 12
Title
Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Description
Orgasmic Function domain: 0/poor - 5/good scoring scale for each of 2 questions (0-10/good). Over last month, when you had sexual stimulation or intercourse how often did you ejaculate? When you had sexual stimulation or intercourse how often did you have the feeling of orgasm (with or without ejaculation)?
Time Frame
Baseline and Week 12
Title
Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Description
Sexual Desire domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how often have you felt sexual desire? How would you rate your level of sexual desire?
Time Frame
Baseline and Week 12
Title
Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
Description
Overall Satisfaction domain: 1/poor - 5/good scoring scale for each of 2 questions (2-10/good). Over last month, how satisfied have you been with your overall sex life? How satisfied have you been with your sexual relationship with your partner?
Time Frame
Baseline and Week 12
Title
Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population
Description
While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders)
Time Frame
Week 12
Title
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT
Description
EDITS -sum of responses (mapped to 0/bad-4/good scale, 11 questions standardized to scale of 100): How satisfied are you w/treatment? How likely to continue?, During past 4 wks, has treatment met expectations? How easy to use ? How satisfied w/how quickly it works? How long it lasts? How confident has it made you feel about ability to engage in sex? How satisfied is partner is with treatment effects? How does your partner feel about continuing use? How natural did process of achieving erection feel? Compared to before erection problem, how natural did erection feel in terms of hardness?
Time Frame
Baseline and Week 12
Title
Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
Description
PASE: Chose one: 1) No evidence of tumescence or erection 2) partial tumescence or erection (not likely to be sufficient for penetration) 3) greater tumescence or erection sufficient for vaginal penetration, but not fully rigid 4) full rigidity; scale 1/poor, no evidence of erection - 4/good, full rigidity
Time Frame
Baseline and Week 12
Title
Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT
Description
SEP Question 1: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Time Frame
Baseline and Weeks 1-12
Title
Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT
Description
SEP Question 4: Were you satisfied with the hardness of your erection? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Time Frame
Baseline and Weeks 1-12
Title
Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT
Description
SEP Question 5: Were you satisfied with this overall sexual experience? yes/no response. Percent yes responses at baseline compared with percent yes responses in overall study treatment period.
Time Frame
Baseline and Weeks 1-12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male, at least 19 years of age Stable monogamous relationship for at least 6 months with a consenting female partner who is at least 19 years of age, vaginal intercourse is a required study activity History of ED (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration Partner is not pregnant or lactating Exclusion Criteria: History of new-onset symptomatic coronary artery disease within the last 3 months or a history of myocardial infarction or cardiac surgical procedure within six months 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 such as Viagra®, Cialis® or Levitra® Previously failed to respond to PDE-5 inhibitors such as Viagra®, Cialis® or Levitra®
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
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
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
Chino
State/Province
California
ZIP/Postal Code
91710
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 Investigational Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
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 Investigational Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
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
Ocala
State/Province
Florida
ZIP/Postal Code
34471
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
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
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
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
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
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
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
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
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
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
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
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
17604-3200
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
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
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

12. IPD Sharing Statement

Learn more about this trial

Treatment of Erectile Dysfunction II

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