A Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effect of Tadalafil Once Daily for 8 Weeks on Prostatic Blood Flow and Perfusion Parameters in Men with Signs and Symptoms of Benign Prostatic Hyperplasia - LVIR

INTERVENTION: Trade Name: CIALIS 5 mg film‐coated tablets Product Name: Tadalafil Product Code: LY450190 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: 5‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Benign Prostatic Hyperplasia (BPH) ; MedDRA version: 14.0 Level: PT Classification code 10004446 Term: Benign prostatic hyperplasia System Organ Class: 10038604 ‐ Reproductive system and breast disorders PRIMARY OUTCOME: Main Objective: The primary objective of Study LVIR is to evaluate the effect of tadalafil 5 mg once daily for 8 weeks compared with placebo on improving prostatic blood perfusion in men with signs and symptoms of BPH, also referred to as BPH‐LUTS (lower urinary tract symptoms), as measured by arterial resistive index (RI) in the prostate transition zone. Primary end point(s): The primary endpoint, and basis for comparison between treatment groups, will be the change from baseline in prostatic transitional zone resistive index (RI) from baseline to Week 8. Secondary Objective: The secondary objectives of the study are as follows:; •To evaluate the effect of tadalafil 5 mg once daily for 8 weeks versus placebo on other regional blood flow and perfusion parameters in the prostate as measured by: Color Doppler ultrasound pixel intensity (color pixel intensity, CPI) in the prostate transition zone and arterial RI and CPI in prostate peripheral zone ; • To evaluate the effect of tadalafil 5 mg once daily for 8 weeks versus placebo on blood flow and perfusion parameters in the bladder neck as measured by arterial RI and CPI; • To evaluate the effect of tadalafil 5 mg once daily for 4 weeks versus placebo on all of the above blood flow and perfusion parameters in the prostate and bladder neck; INCLUSION CRITERIA: Subjects are eligible to be included in the study only if they meet all of the following criteria: [1] Present with benign prostatic hyperplasia (BPH; also referred to as BPH‐LUTS [lower urinary tract symptoms]) based on the disease diagnostic criteria at screening. [2] Are men 45 years of age or older at screening. [3] Provide signed informed consent at screening. [4] Agree not to use any other approved or experimental pharmacologic BPH, overactive bladder (OAB), or erectile dysfunction (ED) treatments, including alpha blockers, 5‐alpha reductase inhibitors (5‐ARIs), antimuscarinics, phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at any time during the study. [5] Have not taken the following treatments within the indicated duration: • Finasteride therapy for at least 3 months prior to the TRUS assessment period. • Dutasteride therapy for at least 6 months prior to the TRUS assessment period. • All other BPH th