Assess Safety & Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

Phase 2CompletedNCT01939184

Warner Chilcott796 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

796

Conditions

Benign Prostatic Hyperplasia

Interventions

WC3055DRUG

12.5, 25, 50 or 75 mg dose

PlaceboOTHER

Placebo

Eligibility

Sex: MALEMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * History of LUTS for ≥6 months secondary to BPH * Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening Exclusion Criteria: \-

Locations (95)

Outcomes

Primary Outcomes

Change from Baseline in Total IPSS (International Prostate Symptom Score)

Sum of Questions 1-7.

Time frame: Final Visit (Week 12 or final visit)

Secondary Outcomes

Change from Baseline Total IPSS

Sum of Questions 1-7.

Time frame: Week 4

Change from Baseline Total IPSS

Sum of Questions 1-7.

Time frame: Week 8

Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score

Questions 1, 2, 3, 4, 5, \& 15.

Time frame: Week 4

Change from Baseline IIEF-EF Domain Score

Questions 1, 2, 3, 4, 5, \& 15.

Time frame: Week 8

Change from Baseline IIEF-EF Domain Score

Questions 1, 2, 3, 4, 5, \& 15.

Time frame: Week 12

Change from Baseline IIEF-EF Domain Score

Questions 1, 2, 3, 4, 5, \& 15.

Time frame: Final Visit (Week 12 or Final Visit)

Data from ClinicalTrials.gov

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