Treatment of Erectile Dysfunction I

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

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).

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Placebo; Drug: Udenafil

• Study Type: Interventional
• Enrollment (Actual): 618
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Warner Chilcott Investigational Site
    • Homewood, Alabama, United States, 35209
      • Warner Chilcott Investigational Site
  • Arizona
    • Mesa, Arizona, United States, 85213
      • Warner Chilcott Investigational Site
    • Phoenix, Arizona, United States, 85023
      • Warner Chilcott Investigational Site
    • Tucson, Arizona, United States, 85741
      • Warner Chilcott Investigational Site
  • California
    • Laguna Hills, California, United States, 92653
      • Warner Chilcott Investigational Site
    • Newport Beach, California, United States, 92660
      • Warner Chilcott Investigational Site
    • San Diego, California, United States, 92103
      • Warner Chilcott Investigational Site
    • Torrance, California, United States, 90505
      • Warner Chilcott Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80211
      • Warner Chilcott Investigational Site
  • Connecticut
    • Middlebury, Connecticut, United States, 06762
      • Warner Chilcott Investigational Site
    • New Britain, Connecticut, United States, 06052
      • Warner Chilcott Investigational Site
    • Waterbury, Connecticut, United States, 06708
      • Warner Chilcott Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33761
      • Warner Chilcott Investigational Site
    • Miami, Florida, United States, 33143
      • Warner Chilcott Investigational Site
    • Ocala, Florida, United States, 34474
      • Warner Chilcott Investigational Site
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Warner Chilcott Investigational Site
  • Illinois
    • Melrose Park, Illinois, United States, 60160
      • Warner Chilcott Investigational Site
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • Warner Chilcott Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Warner Chilcott Investigational Site
  • New York
    • Garden City, New York, United States, 11530
      • Warner Chilcott Investigational Site
    • New York, New York, United States, 10016
      • Warner Chilcott Investigational Site
    • Rochester, New York, United States, 14609
      • Warner Chilcott Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Warner Chilcott Investigational Site
    • Charlotte, North Carolina, United States, 28226
      • Warner Chilcott Investigational Site
    • Concord, North Carolina, United States, 28025
      • Warner Chilcott Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • Warner Chilcott Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • Warner Chilcott Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45212
      • Warner Chilcott Investigational Site
  • Pennsylvania
    • Bala Cynwyd, Pennsylvania, United States, 19004
      • Warner Chilcott Investigational Site
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
      • Warner Chilcott Investigational Site
    • Myrtle Beach, South Carolina, United States, 29572
      • Warner Chilcott Investigational Site
  • Texas
    • Sugar Land, Texas, United States, 77479
      • Warner Chilcott Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Warner Chilcott Investigational Site
  • Washington
    • Spokane, Washington, United States, 99204
      • Warner Chilcott Investigational Site
    • Spokane, Washington, United States, 99208
      • Warner Chilcott Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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®

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Tablets via oral administration before an attempt at sexual intercourse.
Experimental: Udenafil 50 mg	Drug: Udenafil; Tablets via oral administration before an attempt at sexual intercourse.
Experimental: Udenafil 100 mg	Drug: Udenafil; Tablets via oral administration before an attempt at sexual intercourse.
Experimental: Udenafil 150 mg	Drug: Udenafil; Tablets via oral administration before an attempt at sexual intercourse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	Baseline and Week 12
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.	Baseline and Weeks 1 - 12
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.	Baseline and Weeks 1 - 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population		Week 12
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)	Baseline to Week 12
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?	Baseline to Week 12
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?	Baseline and Week 12
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)?	Baseline and Week 12
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?	Baseline and Week 12
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?	Baseline and Week 12
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.	Baseline and Weeks 1 - 12
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.	Baseline and Weeks 1 - 12
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.	Baseline and Weeks 1 - 12

Collaborators and Investigators

• Sponsor: Warner Chilcott
• Investigators: Study Director: Herman Ellman, MD, Warner Chilcott

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: October 19, 2009
• First Submitted That Met QC Criteria: December 18, 2009
• First Posted (Estimate): December 22, 2009

Study Record Updates

• Last Update Posted (Estimate): December 22, 2011
• Last Update Submitted That Met QC Criteria: December 21, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Udenafil
• Other Study ID Numbers: PR-01209