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Treatment of Erectile Dysfunction I

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

Udenafil 50 mg

Udenafil 100 mg

Udenafil 150 mg

Arm Description

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 (poor) - 5/(good) scoring scale for each of 6 questions (0-30/max/good). Over last month: How often were you able to get an erection during sex? 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?
Change 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; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Change in 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; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.

Secondary Outcome Measures

Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population
Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
PSAE, select one of the following: 1) no evidence of any tumescence or erection, 2) partial tumescence or erection (not likely to be sufficient for penetration), 3) great tumescence or erection sufficient for vaginal penetration, but not fully rigid, 4) full rigidity, scale 1/no evidence of erection (min) to 4/full erection (max)
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population
EDITS-derived score is sum of responses, range 0/bad-4/good, 11 questions, standardized to scale of 100: How satisfied 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 made you feel to engage in sex? How satisfied do you believe your partner is with treatment effects? How does your partner feel about your 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 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?
Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT
Question 1 SEP: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT
Question 4 SEP: Were you satisfied with the hardness of your erection? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT
Question 5 SEP: Were you satisfied with this overall sexual experience? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.

Full Information

First Posted
October 19, 2009
Last Updated
December 21, 2011
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT01037244
Brief Title
Treatment of Erectile Dysfunction I
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
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 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).

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
618 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Udenafil 50 mg
Arm Type
Experimental
Arm Title
Udenafil 100 mg
Arm Type
Experimental
Arm Title
Udenafil 150 mg
Arm Type
Experimental
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 (poor) - 5/(good) scoring scale for each of 6 questions (0-30/max/good). Over last month: How often were you able to get an erection during sex? 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
Change 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; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Time Frame
Baseline and Weeks 1 - 12
Title
Change in 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; no scale. Measured percent yes responses during baseline and compared with percent yes responses during overall treatment period.
Time Frame
Baseline and Weeks 1 - 12
Secondary Outcome Measure Information:
Title
Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population
Time Frame
Week 12
Title
Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
Description
PSAE, select one of the following: 1) no evidence of any tumescence or erection, 2) partial tumescence or erection (not likely to be sufficient for penetration), 3) great tumescence or erection sufficient for vaginal penetration, but not fully rigid, 4) full rigidity, scale 1/no evidence of erection (min) to 4/full erection (max)
Time Frame
Baseline to Week 12
Title
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population
Description
EDITS-derived score is sum of responses, range 0/bad-4/good, 11 questions, standardized to scale of 100: How satisfied 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 made you feel to engage in sex? How satisfied do you believe your partner is with treatment effects? How does your partner feel about your 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 to Week 12
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
Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT
Description
Question 1 SEP: Were you able to achieve at least some erection (some enlargement of the penis)? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall 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
Question 4 SEP: Were you satisfied with the hardness of your erection? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall 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
Question 5 SEP: Were you satisfied with this overall sexual experience? yes/no response. Measured percent yes responses during baseline and compared with percent yes responses during overall 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
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
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
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
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
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
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
Warner Chilcott Investigational 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
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
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
34474
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
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
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
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
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
New York
State/Province
New York
ZIP/Postal Code
10016
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
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Warner Chilcott Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28226
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
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
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
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
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
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

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Treatment of Erectile Dysfunction I

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