Benign Prostatic Hyperplasia Clinical Trial
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)
| Verified date | June 2015 |
| Source | Warner Chilcott |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 796 |
| Est. completion date | April 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 45 Years and older |
| Eligibility |
Inclusion Criteria: - History of LUTS for =6 months secondary to BPH - Total IPSS (International Prostate Symptom Score) = 13 at Screening Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Warner Chilcott Investigational Study Site | Albany | New York |
| United States | Warner Chilcott Investigational Study Site | Albuquerque | New Mexico |
| United States | Warner Chilcott Investigational Study Site | Anderson | Indiana |
| United States | Warner Chilcott Investigational Study Site | Atlanta | Georgia |
| United States | Warner Chilcott Investigational Study Site | Austin | Texas |
| United States | Warner Chilcott Investigational Study Site | Aventura | Florida |
| United States | Warner Chilcott Investigational Study Site | Bala Cynwyd | Pennsylvania |
| United States | Warner Chilcott Investigational Study Site | Bristol | Tennessee |
| United States | Warner Chilcott Investigational Study Site | Brookline | Massachusetts |
| United States | Warner Chilcott Investigational Study Site | Brooklyn | New York |
| United States | Warner Chilcott Investigational Study Site | Cary | North Carolina |
| United States | Warner Chilcott Investigational Study Site | Chandler | Arizona |
| United States | Warner Chilcott Investigational Study Site | Charleston | South Carolina |
| United States | Warner Chilcott Investigational Study Site | Charlotte | North Carolina |
| United States | Warner Chilcott Investigational Study Site | Chicago | Illinois |
| United States | Warner Chilcott Investigational Study Site | Cincinnati | Ohio |
| United States | Warner Chilcott Investigational Study Site | Cincinnati | Ohio |
| United States | Warner Chilcott Investigational Study Site | Cincinnati | Ohio |
| United States | Warner Chilcott Investigational Study Site | Clearwater | Florida |
| United States | Warner Chilcottt Investigational Study Site | Clearwater | Florida |
| United States | Warner Chilcott Investigational Study Site | Coeur d'Alene | Idaho |
| United States | Warner Chilcott Investigational Study Site | Colorado Springs | Colorado |
| United States | Warner Chilcott Investigational Study Site | Columbus | Ohio |
| United States | Warner Chilcott Investigational Study Site | Columbus | Ohio |
| United States | Warner Chilcott Investigational Study Site | Concord | North Carolina |
| United States | Warner Chilcott Investigational Study Site | Dallas | Texas |
| United States | Warner Chilcott Investigational Study Site | Denver | Colorado |
| United States | Warner Chilcott Investigational Study Site | Denver | Colorado |
| United States | Warner Chilcott Investigational Study Site | Denver | Colorado |
| United States | Warner Chilcott Investigational Study Site | Elkridge | Maryland |
| United States | Warner Chilcott Investigational Study Site | Englewood | Colorado |
| United States | Warner Chilcott Investigational Study Site | Evanston | Illinois |
| United States | Warner Chilcott Investigational Study Site | Fort Wayne | Indiana |
| United States | Warner Chilcott Investigational Study Site | Garden City | New York |
| United States | Warner Chilcott Investigational Study Site | Gilbert | Arizona |
| United States | Warner Chilcott Investigational Study Site | Glen Burnie | Maryland |
| United States | Warner Chilcott Investigational Study Site | Glendale | Arizona |
| United States | Warner Chilcott Investigational Study Site | Great Neck | New York |
| United States | Warner Chilcott Investigational Study Site | Hialeah | Florida |
| United States | Warner Chilcott Investigational Study Site | High Point | North Carolina |
| United States | Warner Chilcott Investigational Study Site | Homewood | Alabama |
| United States | Warner Chilcott Investigational Study Site | Huntsville | Alabama |
| United States | Warner Chilcott Investigational Study Site | Jacksonville | Florida |
| United States | Warner Chilcott Investigational Study Site | Jeffersonville | Indiana |
| United States | Warner Chilcott Investigational Study Site | Kingston | New York |
| United States | Warner Chilcott Investigational Study Site | Kissimmee | Florida |
| United States | Warner Chilcott Investigational Study Site | Laguna Hills | California |
| United States | Warner Chilcott Investigational Study Site | Lancaster | Pennsylvania |
| United States | Warner Chilcott Investigational Study Site | Las Vegas | Nevada |
| United States | Warner Chilcott Investigational Study Site | Lawrenceville | New Jersey |
| United States | Warner Chilcott Investigational Study Site | Lyndhurst | Ohio |
| United States | Warner Chilcott Investigational Study Site | Melrose Park | Illinois |
| United States | Warner Chilcott Investigational Study Site | Miami | Florida |
| United States | Warner Chilcott Investigational Study Site | Miami | Florida |
| United States | Warner Chilcott Investigational Study Site | Middlebury | Connecticut |
| United States | Warner Chilcott Investigational Study Site | Mobile | Alabama |
| United States | Warner Chilcott Investigational Study Site | Mountlake Terrace | Washington |
| United States | Warner Chilcott Investigational Study Site | Muncie | Indiana |
| United States | Warner Chilcott Investigational Study Site | Murrieta | California |
| United States | Warner Chilcott Investigational Study Site | Myrtle Beach | South Carolina |
| United States | Warner Chilcott Investigational Study Site | New Britain | Connecticut |
| United States | Warner Chilcott Investigational Study Site | New York | New York |
| United States | Warner Chilcott Investigational Study Site | Newburgh | New York |
| United States | Warner Chilcott Investigational Study Site | Newburgh | Indiana |
| United States | Warner Chilcott Investigational Study Site | Ocala | Florida |
| United States | Warner Chilcott Investigational Study Site | Omaha | Nebraska |
| United States | Warner Chilcott Investigational Study Site | Overland Park | Kansas |
| United States | Warner Chilcott Investigational Study Site | Owing Mills | Maryland |
| United States | Warner Chilcott Investigational Study Site | Parker | Colorado |
| United States | Warner Chilcott Investigational Study Site | Pembroke Pines | Florida |
| United States | Warner Chilcott Investigational Study Site | Phoenix | Arizona |
| United States | Warner Chilcott Investigational Study Site | Poughkeepsie | New York |
| United States | Warner Chilcott Investigational Study Site | Raleigh | North Carolina |
| United States | Warner Chilcott Investigational Study Site | Raleigh | North Carolina |
| United States | Warner Chilcott Investigational Study Site | Reading | Pennsylvania |
| United States | Warner Chilcott Investigational Study Site | Salisbury | North Carolina |
| United States | Warner Chilcott Investigational Study Site | Salt Lake City | Utah |
| United States | Warner Chilcott Investigational Study Site | San Antonio | Texas |
| United States | Warner Chilcott Investigational Study Site | San Diego | California |
| United States | Warner Chilcott Investigational Study Site | San Diego | California |
| United States | Warner Chilcott Investigational Study Site | San Diego | California |
| United States | Warner Chilcott Investigational Study Site | San Diego | California |
| United States | Warner Chilcott Investigational Study Site | Sandy Springs | Georgia |
| United States | Warner Chilcott Investigational Study Site | Shreveport | Louisiana |
| United States | Warner Chilcott Investigational Study Site | Springfield | Illinois |
| United States | Warner Chilcott Investigational Study Site | Springfield | Illinois |
| United States | Warner Chilcott Investigational Study Site | Tallahassee | Florida |
| United States | Warner Chilcott Investigational Study Site | Towson | Maryland |
| United States | Warner Chilcott Investigational Study Site | Virginia Beach | Virginia |
| United States | Warner Chilcott Investigational Study Site | Warwick | Rhode Island |
| United States | Warner Chilcott Investigational Study Site | Wauwatosa | Wisconsin |
| United States | Warner Chilcott Investigational Study Site | West Des Moines | Iowa |
| United States | Warner Chilcott Investigational Study Site | Wilmington | North Carolina |
| United States | Warner Chilcott Investigational Study Site | Winchester | Virginia |
| United States | Warner Chilcott Investigational Study Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Warner Chilcott |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline in Total IPSS (International Prostate Symptom Score) | Sum of Questions 1-7. | Final Visit (Week 12 or final visit) | No |
| Secondary | Change from Baseline Total IPSS | Sum of Questions 1-7. | Week 4 | No |
| Secondary | Change from Baseline Total IPSS | Sum of Questions 1-7. | Week 8 | No |
| Secondary | Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score | Questions 1, 2, 3, 4, 5, & 15. | Week 4 | No |
| Secondary | Change from Baseline IIEF-EF Domain Score | Questions 1, 2, 3, 4, 5, & 15. | Week 8 | No |
| Secondary | Change from Baseline IIEF-EF Domain Score | Questions 1, 2, 3, 4, 5, & 15. | Week 12 | No |
| Secondary | Change from Baseline IIEF-EF Domain Score | Questions 1, 2, 3, 4, 5, & 15. | Final Visit (Week 12 or Final Visit) | No |
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