Clinical trial NCT01037218: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2009-12-22
Enrollment: 601
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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®

Primary outcomes:
measure: 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)
timeFrame: Baseline and Week 12
measure: Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT
timeFrame: Baseline and Weeks 1-12
measure: Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT
timeFrame: Baseline and Weeks 1-12
Secondary outcomes:
measure: Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
timeFrame: Baseline and Week 12
measure: Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
timeFrame: Baseline and Week 12
measure: Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
timeFrame: Baseline and Week 12
measure: Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF
timeFrame: Baseline and Week 12
measure: Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population
timeFrame: Week 12
measure: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT
timeFrame: Baseline and Week 12
measure: Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
timeFrame: Baseline and Week 12
measure: Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT
timeFrame: Baseline and Weeks 1-12
measure: Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT
timeFrame: Baseline and Weeks 1-12
measure: Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT
timeFrame: Baseline and Weeks 1-12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Warner Chilcott Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Warner Chilcott Investigational Site
state: Alabama
city: Tempe
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Chino
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Tarzana
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Englewood
country: United States
facility: Warner Chilcott Investigational Site
state: Colorado
city: Milford
country: United States
facility: Warner Chilcott Investigational Site
state: Connecticut
city: Aventura
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: DeLand
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Ocala
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Tampa
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Dawsonville
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Fort Wayne
country: United States
facility: Warner Chilcott Investigational Site
state: Indiana
city: Greenwood
country: United States
facility: Warner Chilcott Investigational Site
state: Indiana
city: West Des Moines
country: United States
facility: Warner Chilcott Investigational Site
state: Iowa
city: Elkridge
country: United States
facility: Warner Chilcott Investigational Site
state: Maryland
city: Greenbelt
country: United States
facility: Warner Chilcott Investigational Site
state: Maryland
city: Las Vegas
country: United States
facility: Warner Chilcott Investigational Site
state: Nevada
city: Lawrenceville
country: United States
facility: Warner Chilcott Investigational Site
state: New Jersey
city: Bay Shore
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Brooklyn
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Kingston
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: New York
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Williamsville
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Cary
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Warner Chilcott Investigational Site
state: Ohio
city: Jenkintown
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Arlington
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Warner Chilcott Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Warner Chilcott Investigational Site
state: Virginia
city: Mountlake Terrace
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
Study officials:
affiliation: Warner Chilcott
name: Herman Ellman, MD
role: STUDY_DIRECTOR
References: