Treatment of Erectile Dysfunction II

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: NCT01037218
• Other study ID #: PR-01309
• Status: Completed
• Phase: Phase 3
• First received: October 19, 2009
• Last updated: May 20, 2015
• Start date: September 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2015
• 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 601
• Est. completion date: April 2010
• Est. primary completion date: April 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	Arlington	Texas
United States	Warner Chilcott Investigational Site	Aventura	Florida
United States	Warner Chilcott Investigational Site	Bay Shore	New York
United States	Warner Chilcott Investigational Site	Birmingham	Alabama
United States	Warner Chilcott Investigational Site	Brooklyn	New York
United States	Warner Chilcott Investigational Site	Cary	North Carolina
United States	Warner Chilcott Investigational Site	Chino	California
United States	Warner Chilcott Investigational Site	Cleveland	Ohio
United States	Warner Chilcott Investigational Site	Dawsonville	Georgia
United States	Warner Chilcott Investigational Site	Daytona Beach	Florida
United States	Warner Chilcott Investigational Site	DeLand	Florida
United States	Warner Chilcott Investigational Site	Elkridge	Maryland
United States	Warner Chilcott Investigational Site	Englewood	Colorado
United States	Warner Chilcott Investigational Site	Fort Wayne	Indiana
United States	Warner Chilcott Investigational Site	Greenbelt	Maryland
United States	Warner Chilcott Investigational Site	Greenwood	Indiana
United States	Warner Chilcott Investigational Site	Greer	South Carolina
United States	Warner Chilcott Investigational Site	Huntsville	Alabama
United States	Warner Chilcott Investigational Site	Jenkintown	Pennsylvania
United States	Warner Chilcott Investigational Site	Kingston	New York
United States	Warner Chilcott Investigational Site	Lancaster	Pennsylvania
United States	Warner Chilcott Investigational Site	Las Vegas	Nevada
United States	Warner Chilcott Investigational Site	Lawrenceville	New Jersey
United States	Warner Chilcott Investigational Site	Milford	Connecticut
United States	Warner Chilcott Investigational Site	Mountlake Terrace	Washington
United States	Warner Chilcott Investigational Site	New York	New York
United States	Warner Chilcott Investigational Site	Norfolk	Virginia
United States	Warner Chilcott Investigational Site	Ocala	Florida
United States	Warner Chilcott Investigational Site	Poughkeepsie	New York
United States	Warner Chilcott Investigational Site	Raleigh	North Carolina
United States	Warner Chilcott Investigational Site	Raleigh	North Carolina
United States	Warner Chilcott Investigational Site	Richmond	Virginia
United States	Warner Chilcott Investigational Site	Salisbury	North Carolina
United States	Warner Chilcott Investigational Site	San Antonio	Texas
United States	Warner Chilcott Investigational Site	Sandy Springs	Georgia
United States	Warner Chilcott Investigational Site	Tampa	Florida
United States	Warner Chilcott Investigational Site	Tarzana	California
United States	Warner Chilcott Investigational Site	Tempe	Arizona
United States	Warner Chilcott Investigational Site	West Des Moines	Iowa
United States	Warner Chilcott Investigational Site	Williamsville	New York

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 - 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?	Baseline and Week 12	No
Primary	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.	Baseline and Weeks 1-12	No
Primary	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.	Baseline and Weeks 1-12	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	Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population	While Using the Study Medication, Did You Feel That Your Erections Improved (Yes Responders)	Week 12	No
Secondary	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?	Baseline and Week 12	No
Secondary	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	Baseline and Week 12	No
Secondary	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.	Baseline and Weeks 1-12	No
Secondary	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.	Baseline and Weeks 1-12	No
Secondary	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.	Baseline and Weeks 1-12	No