A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Effect on Unassisted Erectile Function of the Early Use of Tadalafil 5 mg Once a Day and Tadalafil 20 mg On Demand Treatment for 9 Months in Subjects Undergoing Bilateral Nerve-Sparing Radical Prostatectomy
- Conditions
- Erectile dysfunction following Bilateral Nerve-Sparing Radical ProstatectomyMedDRA version: 14.1Level: PTClassification code 10061461Term: Erectile dysfunctionSystem Organ Class: 10038604 - Reproductive system and breast disordersMedDRA version: 14.1Level: PTClassification code 10050756Term: Radical prostatectomySystem Organ Class: 10042613 - Surgical and medical procedures
- Registration Number
- EUCTR2009-011850-17-PL
- Lead Sponsor
- Eli Lilly and Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 412
-Male and aged >=18 years at Visit 1, and <65 years at time of BNSRP.
-Able to read, understand and provide signed informed consent.
-Have no history of ED at Visit 1, and a normal preoperative erectile function score, without the use of therapy or devices for the improvement of erections.
-Are scheduled to undergo bilateral NSRP surgery for organ-confined, non-metastatic prostate cancer up to approximately 6 weeks after Visit 1.
-Have an interest in resuming sexual activity as soon as possible after surgery and anticipate having the same adult female sexual partner during the study.
-Have a historical total PSA level <10 ng/mL prior to Visit 1.
-Have a clinical stage of prostate cancer of T1c to T2c.
-Have a biopsy Gleason score <=7.
-Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study.
-Agree to participate in recording responses to questionnaires and other instruments used in this study.
Post-Surgical Inclusion Criteria
-Have an operating report with confirmation of bilateral nerve-sparing during the prostatectomy procedure, as determined by a total (composite) score of 3 or less.
-Have Grade 0-3 Residual Erectile Function, as measured at Visit 4.
-Have developed ED after surgery, as measured at Visit 4.
-Have a final pathological stage that does not require the initiation of adjuvant therapy for prostate cancer.
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
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 <90 mmHg or diastolic BP >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
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