Clinical trial NCT01037244: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2009-12-22
Enrollment: 618
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).


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: Change in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT
timeFrame: Baseline and Weeks 1 - 12
measure: Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT
timeFrame: Baseline and Weeks 1 - 12
Secondary outcomes:
measure: Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population
timeFrame: Week 12
measure: Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population
timeFrame: Baseline to Week 12
measure: Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population
timeFrame: Baseline to Week 12
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: 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: Homewood
country: United States
facility: Warner Chilcott Investigational Site
state: Alabama
city: Mesa
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Laguna Hills
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Newport Beach
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Torrance
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Denver
country: United States
facility: Warner Chilcott Investigational Site
state: Colorado
city: Middlebury
country: United States
facility: Warner Chilcott Investigational Site
state: Connecticut
city: New Britain
country: United States
facility: Warner Chilcott Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: Warner Chilcott Investigational Site
state: Connecticut
city: Clearwater
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Ocala
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Columbus
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Melrose Park
country: United States
facility: Warner Chilcott Investigational Site
state: Illinois
city: Jeffersonville
country: United States
facility: Warner Chilcott Investigational Site
state: Indiana
city: Omaha
country: United States
facility: Warner Chilcott Investigational Site
state: Nebraska
city: Garden City
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: Rochester
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Chapel Hill
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Concord
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Warner Chilcott Investigational Site
state: Ohio
city: Bala Cynwyd
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Sugar Land
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Spokane
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
city: Spokane
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
Study officials:
affiliation: Warner Chilcott
name: Herman Ellman, MD
role: STUDY_DIRECTOR
References: