A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multinational Study to Evaluate the Efficacy and Safety of Tadalafil 2.5 and 5 mg Once Daily Dosing for 12 Weeks for the Treatment of Erectile Dysfunction and Signs and Symptoms of Benign Prostatic Hyperplasia in Men with Both Erectile Dysfunction and Benign Prostatic Hyperplasia. - LVHR
- Conditions
- Benign prostatic hyperplasia and erectile dysfunction.MedDRA version: 9.1Level: LLTClassification code 10004446Term: Benign prostatic hyperplasiaMedDRA version: 9.1Level: LLTClassification code 10061461Term: Erectile dysfunction
- Registration Number
- EUCTR2008-004337-25-PT
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 501
- men 45 years of age or older at Visit 1.
- present with BPH-LUTS based on the disease diagnostic criteria (Protocol Section 8.1.1 and have a history of ED based on the disease diagnostic criteria (Protocol Section 8.1.2) at Visit 1.
- have LUTS with a Total IPSS =13 at Visit 2.
- have bladder outlet obstruction (Qmax of =4 to =15 mL/second (from a prevoid total bladder volume of =150 to =550 mL and a minimum voided volume of 125 mL) at Visit 2.
- make at least 4 sexual intercourse attempts during the 4-week placebo lead-in period.
- are sexually active with an adult female partner, and expect to remain sexually active with the same adult female partner for the duration of the study.
- demonstrate compliance with study drug administration requirements during the placebo lead-in period by administering =70% of prescribed doses.
- agree not to use any other approved or experimental pharmacologic BPH, OAB, or ED treatments, including alpha blockers, 5-ARIs, antimuscarinics, 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] 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 (including herbal preparations) for at least 4 weeks prior to Visit 2.
[10] Provide signed informed consent at Visit 1.
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
- PSA >10.0 ng/mL at Visit 1.
- PSA =4.0 to =10.0 ng/mL at Visit 1 if prostate malignancy has not been ruled out by a urologist.
- bladder PVR =300 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 (bladder) stones within 6 months
- clinical evidence of severe hepatic impairment at 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] 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 (receiving renal dialysis or an estimated creatinine clearance <30 mL/minute at Visit 1 as calculated using the Cockroft-Gault formula).
- history of ED caused by other primary sexual disorders including premature ejaculation or ED caused by untreated endocrine disease.
- presence of penile deformity judged by the investigator to be clinically significant.
- history of any of the following cardiac conditions:
[a] Chronic stable angina treated with long-acting nitrates.
[b] Angina requiring treatment with short-acting nitrates within 90 days of Visit 1.
[c] Unstable angina within 90 days of Visit 1.
[d] Angina occurring during sexual intercourse in the last 6 months.
[e] Positive cardiac stress test without documented evidence of subsequent, effective cardiac intervention.
- history of any of the following coronary conditions within 90 days of Visit 1:
[a] Myocardial infarction.
[b] Coronary artery bypass graft surgery.
[c] Percutaneous coronary intervention.
- new significant cardiac conduction defect within 90 days prior to Visit 1.
- any supraventricular arrhythmia with an uncontrolled ventricular at rest despite medical or device therapy, or any history of spontaneous or induced sustained ventricular tachycardia despite medical or device therapy, or the presence of an automatic internal cardioverterdefibrillator.
- history of resuscitated cardiac arrest.
- any evidence of heart disease (New York Heart Association [NYHA] = Class II) within 6 months of Visit 1.
- systolic blood pressure >160 or <90 mm Hg or diastolic blood pressure >100 or <50 mm Hg at Visit 1 or malignant hypertension.
- history of human HIV infection.
- scheduled or planned surgery during the course of the study.
- history of significant central nervous system injuries within 6 months of Visit 1.
- history of drug, alcohol, or substance abuse within 6 months of Visit 1.
- any condition that would interfere with subject ability to provide informed consent or comply with
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