Benign Prostatic Hyperplasia (BPH) MedDRA version: 9.1 Level: LLT Classification code 10004446 Term: Benign prostatic hyperplasia
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Men 45 years of age or older at Visit 1. -Provide signed informed consent at Visit 1. -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. -Have not taken the following treatments within the indicated duration: [a] Finasteride therapy for at least 3 months prior to Visit 2. [b] Dutasteride therapy for at least 6 months prior to Visit 2. [c] Other BPH therapy (including herbal preparations) for at least 4 weeks prior to Visit 2. [d] OAB therapy for at least 4 weeks prior to Visit 2. [e] ED therapy for at least 4 weeks prior to Visit 2. [f] Other experimental or off-label BPH therapy, such as injectable therapies with a protracted effect, for at least 1/2 year prior to Visit 2. -Have LUTS with a Total IPSS >=13 at Visit 2. -Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of >=4 to ==150 to==70% of prescribed doses, confirmed by documentation that the subject returned =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -PSA >10.0 ng/mL at Visit 1. -PSA >=4.0 to =300 mL by ultrasound determination at Visit 1. -History of any of the following pelvic conditions: [a] Pelvic surgery or any other pelvic procedure, including radical prostatectomy, pelvic surgery for removal of malignancy, or bowel resection. [b] Pelvic radiotherapy. [c] Any pelvic surgical procedure of the urinary tract, including minimally invasive BPH-LUTS therapies and penile implant surgery. [d] Lower urinary tract malignancy or trauma. -Lower urinary tract instrumentation within 30 days of Visit 1. -History of urinary retention or lower urinary tract stones within 6 months of Visit 1. -History of urethral obstruction due to stricture, valves, sclerosis, or tumor. -Clinical evidence of any of the following bladder conditions: [a] Mullerian duct cysts. [b] Atonic, decompensated, or hypocontractile bladder. [c] Detrusor-sphincter dyssynergia. [d] Intravesical obstruction. [e] Interstitial cystitis. -Clinical evidence of any of the following urinary tract conditions at Visit 1: [a] Urinary tract infection. [b] Urinary tract inflammation. [c] Current antibiotic therapy for urinary tract infection. [d] Clinically significant microscopic hematuria as determined by a urologist. -Clinical evidence of prostate cancer. -Current neurologic disease or condition associated with neurogenic bladder. -History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance =Class III within 6 months of Visit 1. -Systolic blood pressure >160 or 100 or 9% at Visit 1. -Known
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of tadalafil 5 mg once daily for 12 weeks compared with placebo in improving the IPSS in men with signs and symptoms of BPH, also referred to as BPH-LUTS (lower urinary tract symptoms).;Secondary Objective: To evaluate the: -efficacy of tamsulosin 0.4 mg daily compared with placebo in improving IPSS in men with BPH-LUTS. -efficacy of tadalafil 5 mg daily compared with placebo and tamsulosin 0.4 mg daily compared with placebo for in the treatment of men with BPH-LUTS. -efficacy of tadalafil 5 mg daily compared with placebo and tamsulosin 0.4 mg daily compared with placebo after 1 week and 4 weeks of treatment in men with BPH-LUTS as assessed by the modified IPSS (mIPSS). -efficacy of tadalafil 5 mg daily compared with placebo and tamsulosin 0.4 mg daily compared with placebo of treatment in men with BPH-LUTS and ED as assessed by the IIEF-EF Domain. -effect of tadalafil 5 mg daily compared with placebo and tamsulosin 0.4 mg daily compared with placebo in the treatment of men with BPH-LUTS as assessed by uroflowmetry measurements. -safety of tadalafil 5 mg daily and tamsulosin 0.4 mg daily in the treatment of men with BPH-LUTS.;Primary end point(s): Change in IPSS from baseline after 12 weeks. | — |
Countries
Austria, Belgium, France, Germany, Greece, Italy, Netherlands
Outcome results
None listed