Benign Prostatic Hyperplasia (BPH) MedDRA version: 12.1 Level: LLT Classification code 10004446 Term: Benign prostatic hyperplasia
Conditions
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
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, OAB, or ED treatments, including alpha blockers, additional 5 ARIs, antimuscarinics, PDE5 inhibitors, or herbal preparations, at any time during the study. [6] Have not previously taken finasteride or dutasteride at any time prior to screening. [7] Have not previously taken any other short-acting BPH therapy (including herbal preparations), OAB, or ED therapy for at least 4 weeks prior to the start of the placebo lead-in period, or any investigational BPH therapy with an anticipated prolonged effect, within 6 months of screening. [8] Have LUTS with a total IPSS =13 at the start of the placebo lead-in period. [9] 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 the start of the placebo lead-in period. [10] Have prostate enlargement: prostate volume 30 cc or greater on TRUS at screening. [11] Demonstrate compliance with study drug administration requirements during the placebo lead-in period by administering =70% of prescribed doses, confirmed by documentation that the subject returned =30% of prescribed doses at randomization. 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: 12] Prostate-specific antigen levels >10.0 ng/mL at screening. 13] Prostate-specific antigen levels =4.0 to =10.0 ng/mL at screening, if prostate malignancy has not been ruled out to the satisfaction of an urologist. 14] Bladder postvoid residual volume =300 mL by ultrasound determination at the start of the placebo lead-in period. 15] 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]Urologic malignancy or trauma. 16] Lower urinary tract instrumentation within 30 days of screening. 17] History of urinary retention or bladder stones within 6 months of screening 18] History of urethral obstruction due to stricture, valves, sclerosis, or tumor 19] Clinical evidence of any of the following bladder conditions:[a] Mullerian duct cysts [b] Atonic, decompensated, hypocontractile bladder [c] Detrusor-sphinctor dyssynergia [d] Intravesical obstruction [e] Interstitial cystitis 20] Clinical evidence of any of the following urinary tract conditions at screening: [a] Urinary tract infection [b] Urinary tract inflammation [c] Current antibiotic therapy for urinary tract infection. [d] Clinically significant microscopic hematuria 21] Clinical evidence of prostate cancer 22] Current neurologic disease or condition associated with neurogenic bladder 23] History of significant renal insufficiency, defined as receiving renal dialysis or having an estimated creatinine clearance of 160 or 100 or <50 mmHg at screening (if stress is suspected, retest under basal conditions), or malignant hypertension 29] Scheduled or planned surgery (or any procedure requiring general, spinal, or epidural anesthesia) during the course of the study. 30] History of significant central nervous system injuries within 6 months of screening 31] History of drug, alcohol, or substance abuse within 6 months of screening. 32] Any condition that would interfere with the subject’s ability to provide informed consent or comply with study instructions, would place subject at increased risk, or might confound the interpretation of the study results 33] Current treatment with nitrates, androgens, antiandrogens, estrogens, luteinizing hormone-releasing hormone agonists/antagonists, anabolic steroids, antidiuretic hormone, atypical antipsychotics, cancer chemotherapy, serotonin norepinephrine reuptake inhibitors, or tricyclic antidepressants 34]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to test the hypothesis that tadalafil 5 mg once daily co-administered with finasteride is superior to placebo once daily co-administered with finasteride for 12 weeks in improving the International Prostate Symptom Score (IPSS) in men with lower urinary tract symptoms (LUTS) and prostatic enlargement secondary to benign prostatic hyperplasia (BPH).;Secondary Objective: •To examine the impact of tadalafil 5 mg once daily versus placebo when co-administered with finasteride on erectile function in men with LUTS and prostatic enlargement secondary to BPH at 4, 12 and 26 weeks. •To evaluate the change from baseline of tadalafil 5 mg once daily versus placebo when coadministered with finasteride in the treatment of men with LUTS and prostatic enlargement secondary to BPH •To examine the impact of tadalafil 5 mg once daily versus placebo when coadministered with finasteride on urinary symptoms of BPH assessed at 26 weeks in men with LUTS and prostatic enlargement secondary to BPH •To assess the safety of tadalafil 5 mg once daily versus placebo when co-administered with finasteride for 26 weeks in the treatment of men with LUTS and prostatic enlargement secondary to BPH, as examined by the following measures: adverse events; vital signs; clinical laboratory tests; and Postvoid residual volume.;Primary end point(s): The primary efficacy measure is the change in total International Prostate Symptom Score (IPSS) from baseline to 12 weeks of treatment | — |
Countries
France, Germany, Greece, Italy
Outcome results
None listed