Erectile dysfunction following Bilateral Nerve-Sparing Radical Prostatectomy MedDRA version: 12.0 Level: LLT Classification code 10050756 Term: Radical prostatectomy MedDRA version: 12.0 Level: LLT Classification code 10061461 Term: Erectile dysfunction
Conditions
Sponsors
Eli Lilly and Company Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Male and aged >=18 years at Visit 1, and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At Visit 1: -Have a history of ED, with or without treatment. -Have a history of prostatic surgery or prostatic physical treatments. -Have a history of penile implant. -Have a history of drug, alcohol or substance abuse within the previous 6 month. -Have a history of galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption. At Visit 1 or Visit 4: -Have received previous or current treatment with tadalafil or any other PDE5 inhibitor. -Require treatment with doxazosin or nitrates after Visit 4, or have received treatment with cancer chemotherapy, luteinising hormone-releasing hormone (LH-RH) analogues, LH-RH antagonists, or anti-androgens. -Have undergone, or plan to undergo, radiation or hormonal therapy for prostate cancer. -Have ED post-BNSRP caused by untreated endocrine disease. -Have a clinically significant penile deformity. -Have a communicable skin or sexually transmitted disease, or have any rash or lesions on the penis or surrounding area. -Exhibit evidence of clinically significant renal insufficiency. -Exhibit clinical evidence of severe hepatic impairment. -Have a history of diabetes mellitus. -Present with chronic stable angina treated with long-acting nitrates, or with chronic stable angina requiring short-acting nitrates in the previous 90 days, or with angina occurring during sexual intercourse in the previous 6 months. -Have met the criteria for unstable angina within the previous 6 months, or have a history of myocardial infarction or coronary artery bypass graft surgery within the previous 90 days, or percutaneous coronary intervention within the previous 90 days. -Have any supraventricular arrhythmia with an uncontrolled ventricular response (mean heart rate >100 bpm) at rest, or have any history of spontaneous or induced sustained ventricular tachycardia (heart rate >100 bpm for >=30 seconds), or use an automatic internal cardioverter-defibrillator. -Have a history of sudden cardiac arrest. -Exhibit any evidence of congestive heart failure (New York Heart Association [NYHA] Class II or above) within the previous 6 months. -Have a history of new significant cardiac conduction defect within the previous 90 days. -Exhibit systolic BP >170 or 100 or <50 mmHg (if stress is suspected, retest under basal conditions), or have a history of malignant hypertension. -Have a history of significant central nervous system injuries within the previous 6 months. -Have a history of loss of vision in one eye because of nonarteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure. -Have a history of human immunodeficiency virus (HIV) infection. -Have any condition that, in the opinion of the investigator, would interfere with the subject’s ability to provide informed consent or comply with study instructions, would place the subject at increased risk, or might confound the interpretation of the study results. -Are investigator site personnel directly affiliated with this study and/or their immediate family. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. -Are Lilly employees. -Are currently enrolled in, or have discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of tadalafil 5 mg once a day (OAD) and tadalafil 20 mg on demand (PRN), compared with placebo, when taken orally over 9 months, in improving unassisted erectile function in men who develop erectile dysfunction after bilateral nerve-sparing radical prostatectomy.;Secondary Objective: - To evaluate the efficacy of tadalafil 5 mg OaD on drug-assisted erectile function when administered to all subjects at the end of the 3-month, open-label period. - To evaluate the efficacy of tadalafil compared with placebo on drug-assisted erectile function at the end of the 9-month, placebo-controlled period. - To evaluate the efficacy of tadalafil compared with placebo on unassisted erectile function at the end of the washout period. - To evaluate the effect of tadalafil compared with placebo on penile length and girth. - To evaluate the effect of tadalafil compared with placebo on spontaneous morning erections. - To evaluate subjects’ satisfaction with tadalafil compared with placebo. - To evaluate subjects’ and partners’ quality of life following tadalafil compared with placebo. - To evaluate psychosocial outcomes of tadalafil compared with placebo. - To assess the safety of tadalafil 5 mg OaD and tadalafil 20 mg PRN, compared with placebo. ;Primary end point(s): Percentage of subjects with a score of >=22 in the IIEF-EF Domain after 6 week drug-free washout. | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom
Outcome results
None listed