Assess Safety & Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
Phase 2
Completed
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Drug: WC3055Other: Placebo
- Registration Number
- NCT01939184
- Lead Sponsor
- Warner Chilcott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 796
Inclusion Criteria
- History of LUTS for ≥6 months secondary to BPH
- Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening
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Exclusion Criteria
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WC3055-04F WC3055 WC3055 75 mg tablet once daily for 12 weeks WC3055-07P Placebo Placebo tablet once daily for 12 weeks WC3055-01F WC3055 WC3055 12.5 mg tablet once daily for 12 weeks WC3055-02F WC3055 WC3055 25 mg tablet once daily for 12 weeks WC3055-03F WC3055 WC3055 50 mg tablet once daily for 12 weeks
- Primary Outcome Measures
Name Time Method Change from Baseline in Total IPSS (International Prostate Symptom Score) Final Visit (Week 12 or final visit) Sum of Questions 1-7.
- Secondary Outcome Measures
Name Time Method Change from Baseline Total IPSS Week 8 Sum of Questions 1-7.
Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score Week 4 Questions 1, 2, 3, 4, 5, \& 15.
Change from Baseline IIEF-EF Domain Score Final Visit (Week 12 or Final Visit) Questions 1, 2, 3, 4, 5, \& 15.
Trial Locations
- Locations (2)
Warner Chilcott Investigational Study Site
🇺🇸Wauwatosa, Wisconsin, United States
Warner Chilcottt Investigational Study Site
🇺🇸Clearwater, Florida, United States