Treatment of Erectile Dysfunction I

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037244
• Other study ID #: PR-01209
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2009
• Last updated: December 21, 2011
• Start date: September 2009
• Est. completion date: March 2010

Study information

• Verified date: December 2011
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 618
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Udenafil
Tablets via oral administration before an attempt at sexual intercourse.
• Placebo
Tablets via oral administration before an attempt at sexual intercourse.

Locations

Country	Name	City	State
United States	Warner Chilcott Investigational Site	Bala Cynwyd	Pennsylvania
United States	Warner Chilcott Investigational Site	Birmingham	Alabama
United States	Warner Chilcott Investigational Site	Chapel Hill	North Carolina
United States	Warner Chilcott Investigational Site	Charlotte	North Carolina
United States	Warner Chilcott Investigational Site	Cincinnati	Ohio
United States	Warner Chilcott Investigational Site	Clearwater	Florida
United States	Warner Chilcott Investigational Site	Columbus	Georgia
United States	Warner Chilcott Investigational Site	Concord	North Carolina
United States	Warner Chilcott Investigational Site	Denver	Colorado
United States	Warner Chilcott Investigational Site	Garden City	New York
United States	Warner Chilcott Investigational Site	Homewood	Alabama
United States	Warner Chilcott Investigational Site	Jeffersonville	Indiana
United States	Warner Chilcott Investigational Site	Laguna Hills	California
United States	Warner Chilcott Investigational Site	Melrose Park	Illinois
United States	Warner Chilcott Investigational Site	Mesa	Arizona
United States	Warner Chilcott Investigational Site	Miami	Florida
United States	Warner Chilcott Investigational Site	Middlebury	Connecticut
United States	Warner Chilcott Investigational Site	Mt. Pleasant	South Carolina
United States	Warner Chilcott Investigational Site	Myrtle Beach	South Carolina
United States	Warner Chilcott Investigational Site	New Britain	Connecticut
United States	Warner Chilcott Investigational Site	New York	New York
United States	Warner Chilcott Investigational Site	Newport Beach	California
United States	Warner Chilcott Investigational Site	Ocala	Florida
United States	Warner Chilcott Investigational Site	Omaha	Nebraska
United States	Warner Chilcott Investigational Site	Phoenix	Arizona
United States	Warner Chilcott Investigational Site	Rochester	New York
United States	Warner Chilcott Investigational Site	Salt Lake City	Utah
United States	Warner Chilcott Investigational Site	San Diego	California
United States	Warner Chilcott Investigational Site	Spokane	Washington
United States	Warner Chilcott Investigational Site	Spokane	Washington
United States	Warner Chilcott Investigational Site	Sugar Land	Texas
United States	Warner Chilcott Investigational Site	Torrance	California
United States	Warner Chilcott Investigational Site	Tucson	Arizona
United States	Warner Chilcott Investigational Site	Waterbury	Connecticut
United States	Warner Chilcott Investigational Site	Wilmington	North Carolina
United States	Warner Chilcott Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No