A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multicenter Study to Evaluate the Urodynamic Effects of Tadalafil Once a Day for 12 Weeks in Men With Signs and Symptoms of Benign Prostatic Hyperplasia - LVHK

INTERVENTION: Trade Name: Cialis Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Tadalafil CAS Number: 171596‐29‐5 Current Sponsor code: LY450190 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Effects on urodynamic parameters in men with benign prostatic hyperplasia (also referred to as BPH‐LUTS [lower urinary tract symptoms]) with and without urodynamic evidence of bladder outlet obstruction. LUTS include urinary frequency, urgency, intermittency, nocturia, straining, incomplete emptying and weak urinary stream. ; MedDRA version: 9.1 Level: LLT Classification code 10004446 Term: Benign prostatic hyperplasia PRIMARY OUTCOME: Main Objective: To compare the effect of tadalafil 20 mg once a day for 12 weeks on detrusor pressure at peak urinary flow rate versus placebo in men with signs and symptoms of benign prostatic hyperplasia, including lower urinary tract symptoms (BPH LUTS). Primary end point(s): The primary endpoint is the detrusor pressure at maximum flow rate, which is measured during baseline and end of study urodynamics assessments. Secondary Objective: To examine the effects of tadalafil 20 mg once a day for 12 weeks (compared with placebo) on the urodynamic parameters.; ; To assess the safety of tadalafil 20 mg once a day for 12 weeks in the treatment of men with BPH LUTS as examined by the following measures:; ‐ Adverse events; ‐ Clinical laboratory tests; ; To assess the efficacy of tadalafil 20 mg once a day for 12 weeks in the treatment of men with BPH LUTS as examined by the International Prostate Symptom Score (IPSS).; INCLUSION CRITERIA: [1] Present with BPH LUTS based on the disease diagnostic criteria at Visit 1. [2] Are men 45 years of age or older at Visit 1. [3] Provide signed informed consent document at Visit 1. [4] Agree not to use any other approved or experimental pharmacologic treatments for BPH LUTS, including alpha blockers, 5‐alpha reductase inhibitors, PDE5 inhibitors, or herbal preparations at any time during the study. [5] Have not taken the following treatments within the indicated duration: [a] Finasteride or dutasteride therapy for at least 4 months prior to Visit 2. [b] All other LUTS therapy (including herbal preparations) for at least 4 weeks prior to Visit 2. [c] Any PDE5 inhibitor for at least 4 weeks prior to Visit 2. [6] Have LUTS with a total IPSS greater than or equal to 13 under 1 of the following conditions: [a] At Visit 1 if the subject does not require wash out of therapy for BPH LUTS. [b] At Visit 2 if the subject requires wash out