Primary treatment of the signs and symptoms of benign prostatic hyperplasia in men (also referred to as BPH-LUTS [lower urinary tract symptoms]). BPH-LUTS include urinary frequency, urgency, intermittency, nocturia, straining, incomplete emptying, and weak urinary stream.
Conditions
Interventions
Trade Name: Cialis
Product Name: Cialis
Product Code: Tadalafil
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tadalafil
CAS Number: 171596-29-5
Current Sponsor code: LY450190
Concentrat
Sponsors
Lilly ICOS LLC
Eligibility
Sex/Gender
Male
Inclusion criteria
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 ICD at Visit 1. [4] Agree not to use any other approved or experimental pharmacologic BPH or ED treatments, 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 therapy for at least 3 months prior to Visit 2. [b] Dutasteride therapy for at least 12 months prior to Visit 2. [c] All other BPH therapy (including herbal preparations) for at least 4 weeks prior to Visit 2. [d] ED therapy for at least 4 weeks prior to Visit 2. [6] Have LUTS with a total IPSS =13 at Visit 2. [7] Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of =4 to =15 mL/second (from a prevoid total bladder volume [assessed by ultrasound] of =150 to =550 mL and a minimum voided volume of 125 mL) at Visit 2. [8] Demonstrate compliance with study drug administration requirements during the placebo run-in period by administering =70% of prescribed doses, confirmed by documentation that the subject returned =30% of prescribed doses at Visit 3. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [9] PSA >10.0 ng/mL at Visit 1. [10] PSA =4.0 to =10.0 ng/mL at Visit 1 without documentation of a histologic biopsy of the prostate negative for cancer within 12 months of Visit 1. [11] Bladder PVR =300 mL by ultrasound determination at Visit 1. [12] 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 on the urinary tract, including penile implant surgery. [d] Lower urinary tract malignancy or trauma. [13] Lower urinary tract instrumentation (including prostate biopsy) within 30 days of Visit 1. [14] History of urinary retention or lower urinary tract (bladder) stones within 6 months of Visit 1. [15] History of urethral obstruction due to stricture, valves, sclerosis, or tumor. [16] Clinical evidence of any of the following bladder conditions: [a] Mullerian duct cysts. [b] Bladder calculi. [c] Atonic or hypocontractile bladder. [d] Detrusor-sphincter dyssynergia (contraction of the detrusor without sphincter relaxation). [17] Clinical evidence of any of the following urinary tract conditions at Visit 1: [a] Urinary tract infection. [b] Urinary tract inflammation (including prostatitis). [c] Current antibiotic therapy for urinary tract infection. Urinary tract infection/inflammation is defined as a positive result for leukocyte esterase from a urine dipstick or >5 WBC per high powered field on urinalysis from a centrifuged, clean-catch, midstream urine specimen. [18] Intravesical obstruction (for example, intravesical median lobe of the prostate). [19] Clinical evidence of prostate cancer. [20] Current neurologic disease or condition associated with neurogenic bladder (eg, Parkinson’s disease, multiple sclerosis). [21] History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance 160 or 100 or <50 mm Hg at Visit 1 (if stress is suspected, retest under basal conditions), or malignant hypertension. [27] Scheduled or planned surgery (or any procedure requiring general anesthesia) during the course of the study. [28] History of significant central nervous system (CNS) injuries (including stroke or spinal cord injury) within 6 months of Visit 1. [29] History of drug, alcohol, or substance abuse within 6 months of Visit 1. [30] Any condit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that tadalafil 5 mg once a day for 12 weeks is superior to placebo in improving the International Prostate Symptom Score (IPSS) in men with signs and symptoms of benign prostatic hyperplasia.;Secondary Objective: • To examine whether a dose-response relationship exists for placebo and tadalafil 2.5 mg, 5 mg, 10 mg, and 20 mg once a day for 12 weeks in the treatment of BPH-LUTS. • To test the hypothesis that tadalafil 5 mg once a day for 12 weeks is superior to placebo in the treatment of BPH-LUTS. • To examine the impact of tadalafil once a day on erectile function in men with both BPH-LUTS and ED, as assessed by the International Index of Erectile Function (IIEF) Erectile Function Domain.;Primary end point(s): The primary efficacy endpoint is the change in total IPSS change from baseline to Week 12. | — |
Countries
Germany, Italy, Spain, Sweden
Outcome results
None listed