A Phase 3b, randomized, double-blind, placebo-controlled parallel-design study to evaluate the efficacy and safety of tadalafil co-administered with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia - LVIW
- Conditions
- Benign prostic hyperplasiaMedDRA version: 9.1Level: LLTClassification code 10004446
- Registration Number
- EUCTR2010-020604-29-IT
- Lead Sponsor
- Eli Lilly and Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 646
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
12.(PSA)>10.0 ng/mL at screening. 13.PSA>/= 4.0 to /= 300 mL at screening. 15.History of: Pelvic surgery or any other pelvic procedure;Pelvic radiotherapy ;Any pelvic surgical procedure of the urinary tract;Lower urinary tract malignancy or trauma. 16.Lower urinary tract instrumentation within 30 days of screening. 17.History of urinary retention or lower urinary tract stones within 6 months of screening. 18.History of urethral obstruction due to stricture,valves,sclerosis,or tumor . 19. Clinical evidence or medical history of any of the following bladder conditions:Mullerian duct cysts;Atonic,decompensated or hypocontractile bladder;Detrusor-sphincter dyssynergia;Intravesical obstruction;Interstitial cystitis. 20.Clinical evidence of any of the following:Urinary tract infection;Urinary tract inflammation;Current antibiotic therapy for urinary tract infection;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. 24.Clinical evidence of severe hepatic impairment at screening. 25.History of any of the following cardiac conditions:Angina requiring treatment with long-acting nitrates;and requiring treatment with short-acting nitrates within 90 days of screening;Unstable angina within 90 days of screening;Positive cardiac stress test without documented evidence of subsequent,effective cardiac intervention. 26.History of any of the following coronary conditions within 90 days of screening:Myocardial infarction;Coronary artery bypass graft surgery;Percutaneous coronary intervention. 27.Evidence of moderate to severe heart failure within 6 months of screening. 28.Systolic blood pressure >160 or < 90 mmHg or diastolic blood pressure >100 or <50 mmHg at screening or malignant hypertension. 29.Scheduled or planned surgery 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 subject ability to provide informed consent or comply with study instructions. 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.Chronic use or intermittent use of cholinergics,anticholinergics,antimuscarinics,antihistamines,decongestants,sympathomimetics, phenothiazines. 35.Current systemic treatment with:Potent cytochrome P450 3A4 inhibitors;Cytochrome P450 3A4 inducers. 36.HbA1c >9% at Visit 1. 37.Known or suspected hypersensitivity to tadalafil or any other PDE5 inhibitor, finasteride, or any study drug components. 38.Investigator site personnel directly affiliated with this study and/or immediate families. 39.Lilly employees. 40.Currently enrolled in, or discontinued within the last 30 days from a clinical trial. 41.Previously completed or withdrawn from this study or any other study investigating tadalafil. 42. Are currently in or are planning to be in a sexual relationship with a pregnant female or are currently in a relationship where either p
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method