Benign Prostatic Hyperplasia (BPH) MedDRA version: 9.1 Level: LLT Classification code 10004446 Term: Benign prostatic hyperplasia
Conditions
Interventions
Trade Name: Cialis 5 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Tadalafil
CAS Number: 171596-29-5
Current Sponsor code: LY450190
Other descriptive name: TADALAFIL
Co
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: [1] Present with benign prostatic hyperplasia based on the disease diagnostic criteria (Section 4.1.1 of protocol) at Visit 1. [2] Are men 45 years of age or older at Visit 1. [3] Provide signed informed consent at Visit 1. [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: [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] All 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. [6] Have LUTS with a Total International Prostate Symptom Score (IPSS) greater than or equal to 13 at Visit 2. [7] Have bladder outlet obstruction as defined by a urinary peak flow rate (Qmax) of greater than or equal to 4 to less than or equal to 15 mL/second (from a prevoid total bladder volume [assessed by ultrasound] of greater than or equal to 150 to less than or equal 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 lead-in period by administering greater than or equal to 70% of prescribed doses, confirmed by documentation that the subject returned less than or equal to 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] Prostate specific antigen (PSA) > 10.0 ng/mL at Visit 1. [10] PSA greater than or equal to 4.0 to less than or equal to 10.0 ng/mL at Visit 1 if prostate malignancy has not been ruled out to the satisfaction of an urologist. [11] Bladder postvoid residual volume (PVR) greater than or equal to 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. [b] Pelvic radiotherapy. [c] Any pelvic surgical procedure of the urinary tract. [d] Lower urinary tract malignancy or trauma. [13] Lower urinary tract instrumentation within 30 days of Visit 1. [14] History of urinary retention or lower urinary tract 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] Atonic, decompensated, or hypocontractile bladder. [c] Detrusor-sphincter dyssynergia. [d] Intravesical obstruction. [e] Interstitial cystitis. [17] 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 haematuria. [18] Clinical evidence of prostate cancer. [19] Current neurologic disease or condition associated with neurogenic bladder. [20] History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance 160 or 100 or 9% at Visit 1. [33] Known or suspected hypersensitivity to tadalafil or any study drug components. [34] Are investigator site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of tadalafil 5 mg daily for 12 weeks compared with placebo in improving the International Prostate Symptom Score (IPSS) in men with signs and symptoms of benign prostatic hyperplasia (BPH; also referred to as BPH-LUTS [lower urinary tract symptoms]).;Primary end point(s): The primary endpoint is the change in IPSS from baseline after 12 weeks.;Secondary Objective: To evaluate the change from baseline of tadalafil 5 mg daily for 12 weeks compared with placebo in the treatment of men with BPH-LUTS as assessed by BPH Impact Index (BII), IPSS domains and Global Impression of Improvement indices To evaluate the change from baseline of tadalafil 5 mg daily for 12 weeks compared with placebo in the treatment of men with BPH-LUTS as assessed by uroflowmetry measurements To evaluate the change from baseline of tadalafil 5 mg daily compared with placebo after 1 week of treatment in men with BPH-LUTS as assessed by the Modified IPSS To evaluate the change from baseline of tadalafil 5 mg compared with placebo after 4 weeks of treatment in men with BPH-LUTS To examine the impact of tadalafil 5 mg for 12 weeks on erectile function (EF) in men with both BPH-LUTS and erectile dysfunction as assessed by the International Index of Erectile Function EF Domain To assess the safety of tadalafil 5 mg for 12 weeks in the treatment of men with BPH-LUTS | — |
Countries
Germany, Italy
Outcome results
None listed