Clinical trial NCT01939184: Assess Safety & Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
Official title: A Study to Assess the Safety and Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2013-09-11
Enrollment: 796
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of various fixed daily doses of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to BPH.


Eligibility criteria: Inclusion Criteria:

* History of LUTS for ≥6 months secondary to BPH
* Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening

Exclusion Criteria:

-

Primary outcomes:
measure: Change from Baseline in Total IPSS (International Prostate Symptom Score)
timeFrame: Final Visit (Week 12 or final visit)
Secondary outcomes:
measure: Change from Baseline Total IPSS
timeFrame: Week 4
measure: Change from Baseline Total IPSS
timeFrame: Week 8
measure: Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score
timeFrame: Week 4
measure: Change from Baseline IIEF-EF Domain Score
timeFrame: Week 8
measure: Change from Baseline IIEF-EF Domain Score
timeFrame: Week 12
measure: Change from Baseline IIEF-EF Domain Score
timeFrame: Final Visit (Week 12 or Final Visit)
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Warner Chilcott Investigational Study Site
state: Alabama
city: Huntsville
country: United States
facility: Warner Chilcott Investigational Study Site
state: Alabama
city: Mobile
country: United States
facility: Warner Chilcott Investigational Study Site
state: Alabama
city: Chandler
country: United States
facility: Warner Chilcott Investigational Study Site
state: Arizona
city: Gilbert
country: United States
facility: Warner Chilcott Investigational Study Site
state: Arizona
city: Glendale
country: United States
facility: Warner Chilcott Investigational Study Site
state: Arizona
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Study Site
state: Arizona
city: Laguna Hills
country: United States
facility: Warner Chilcott Investigational Study Site
state: California
city: Murrieta
country: United States
facility: Warner Chilcott Investigational Study Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Study Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Study Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Study Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Study Site
state: California
city: Colorado Springs
country: United States
facility: Warner Chilcott Investigational Study Site
state: Colorado
city: Denver
country: United States
facility: Warner Chilcott Investigational Study Site
state: Colorado
city: Denver
country: United States
facility: Warner Chilcott Investigational Study Site
state: Colorado
city: Denver
country: United States
facility: Warner Chilcott Investigational Study Site
state: Colorado
city: Englewood
country: United States
facility: Warner Chilcott Investigational Study Site
state: Colorado
city: Parker
country: United States
facility: Warner Chilcott Investigational Study Site
state: Colorado
city: Middlebury
country: United States
facility: Warner Chilcott Investigational Study Site
state: Connecticut
city: New Britain
country: United States
facility: Warner Chilcott Investigational Study Site
state: Connecticut
city: Aventura
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Clearwater
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Clearwater
country: United States
facility: Warner Chilcottt Investigational Study Site
state: Florida
city: Hialeah
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Jacksonville
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Kissimmee
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Ocala
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Pembroke Pines
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Tallahassee
country: United States
facility: Warner Chilcott Investigational Study Site
state: Florida
city: Atlanta
country: United States
facility: Warner Chilcott Investigational Study Site
state: Georgia
city: Sandy Springs
country: United States
facility: Warner Chilcott Investigational Study Site
state: Georgia
city: Coeur d'Alene
country: United States
facility: Warner Chilcott Investigational Study Site
state: Idaho
city: Chicago
country: United States
facility: Warner Chilcott Investigational Study Site
state: Illinois
city: Evanston
country: United States
facility: Warner Chilcott Investigational Study Site
state: Illinois
city: Melrose Park
country: United States
facility: Warner Chilcott Investigational Study Site
state: Illinois
city: Springfield
country: United States
facility: Warner Chilcott Investigational Study Site
state: Illinois
city: Springfield
country: United States
facility: Warner Chilcott Investigational Study Site
state: Illinois
city: Anderson
country: United States
facility: Warner Chilcott Investigational Study Site
state: Indiana
city: Fort Wayne
country: United States
facility: Warner Chilcott Investigational Study Site
state: Indiana
city: Jeffersonville
country: United States
facility: Warner Chilcott Investigational Study Site
state: Indiana
city: Muncie
country: United States
facility: Warner Chilcott Investigational Study Site
state: Indiana
city: Newburgh
country: United States
facility: Warner Chilcott Investigational Study Site
state: Indiana
city: West Des Moines
country: United States
facility: Warner Chilcott Investigational Study Site
state: Iowa
city: Overland Park
country: United States
facility: Warner Chilcott Investigational Study Site
state: Kansas
city: Shreveport
country: United States
facility: Warner Chilcott Investigational Study Site
state: Louisiana
city: Elkridge
country: United States
facility: Warner Chilcott Investigational Study Site
state: Maryland
city: Glen Burnie
country: United States
facility: Warner Chilcott Investigational Study Site
state: Maryland
city: Owing Mills
country: United States
facility: Warner Chilcott Investigational Study Site
state: Maryland
city: Towson
country: United States
facility: Warner Chilcott Investigational Study Site
state: Maryland
city: Brookline
country: United States
facility: Warner Chilcott Investigational Study Site
state: Massachusetts
city: Omaha
country: United States
facility: Warner Chilcott Investigational Study Site
state: Nebraska
city: Las Vegas
country: United States
facility: Warner Chilcott Investigational Study Site
state: Nevada
city: Lawrenceville
country: United States
facility: Warner Chilcott Investigational Study Site
state: New Jersey
city: Albuquerque
country: United States
facility: Warner Chilcott Investigational Study Site
state: New Mexico
city: Albany
country: United States
facility: Warner Chilcott Investigational Study Site
state: New York
city: Brooklyn
country: United States
facility: Warner Chilcott Investigational Study Site
state: New York
city: Garden City
country: United States
facility: Warner Chilcott Investigational Study Site
state: New York
city: Great Neck
country: United States
facility: Warner Chilcott Investigational Study Site
state: New York
city: Kingston
country: United States
facility: Warner Chilcott Investigational Study Site
state: New York
city: New York
country: United States
facility: Warner Chilcott Investigational Study Site
state: New York
city: Newburgh
country: United States
facility: Warner Chilcott Investigational Study Site
state: New York
city: Poughkeepsie
country: United States
facility: Warner Chilcott Investigational Study Site
state: New York
city: Cary
country: United States
facility: Warner Chilcott Investigational Study Site
state: North Carolina
city: Charlotte
country: United States
facility: Warner Chilcott Investigational Study Site
state: North Carolina
city: Concord
country: United States
facility: Warner Chilcott Investigational Study Site
state: North Carolina
city: High Point
country: United States
facility: Warner Chilcott Investigational Study Site
state: North Carolina
city: Raleigh
country: United States
facility: Warner Chilcott Investigational Study Site
state: North Carolina
city: Raleigh
country: United States
facility: Warner Chilcott Investigational Study Site
state: North Carolina
city: Salisbury
country: United States
facility: Warner Chilcott Investigational Study Site
state: North Carolina
city: Wilmington
country: United States
facility: Warner Chilcott Investigational Study Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Warner Chilcott Investigational Study Site
state: North Carolina
city: Cincinnati
country: United States
facility: Warner Chilcott Investigational Study Site
state: Ohio
city: Cincinnati
country: United States
facility: Warner Chilcott Investigational Study Site
state: Ohio
city: Cincinnati
country: United States
facility: Warner Chilcott Investigational Study Site
state: Ohio
city: Columbus
country: United States
facility: Warner Chilcott Investigational Study Site
state: Ohio
city: Columbus
country: United States
facility: Warner Chilcott Investigational Study Site
state: Ohio
city: Lyndhurst
country: United States
facility: Warner Chilcott Investigational Study Site
state: Ohio
city: Bala Cynwyd
country: United States
facility: Warner Chilcott Investigational Study Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Warner Chilcott Investigational Study Site
state: Pennsylvania
city: Reading
country: United States
facility: Warner Chilcott Investigational Study Site
state: Pennsylvania
city: Warwick
country: United States
facility: Warner Chilcott Investigational Study Site
state: Rhode Island
city: Charleston
country: United States
facility: Warner Chilcott Investigational Study Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Warner Chilcott Investigational Study Site
state: South Carolina
city: Bristol
country: United States
facility: Warner Chilcott Investigational Study Site
state: Tennessee
city: Austin
country: United States
facility: Warner Chilcott Investigational Study Site
state: Texas
city: Dallas
country: United States
facility: Warner Chilcott Investigational Study Site
state: Texas
city: San Antonio
country: United States
facility: Warner Chilcott Investigational Study Site
state: Texas
city: Salt Lake City
country: United States
facility: Warner Chilcott Investigational Study Site
state: Utah
city: Virginia Beach
country: United States
facility: Warner Chilcott Investigational Study Site
state: Virginia
city: Winchester
country: United States
facility: Warner Chilcott Investigational Study Site
state: Virginia
city: Mountlake Terrace
country: United States
facility: Warner Chilcott Investigational Study Site
state: Washington
city: Wauwatosa
country: United States
facility: Warner Chilcott Investigational Study Site
state: Wisconsin
Study officials:
affiliation: Warner Chilcott
name: Herman Ellman, MD
role: STUDY_DIRECTOR
References: