Erectile Dysfunction Classification code 10061461
Conditions
Interventions
Trade Name: Levitra
Product Name: Levitra
Product Code: Bay 38-9456
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: vardenafil (as hydrochoride)
CAS Number: 224785-91-5
Current Sponsor c
Sponsors
Bayer Healthcare AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: At Screening: Males 18-64 years of age Scheduled to undergo bilateral nerve-sparing radical retropubic BNSRRP, as selected according to the investigator’s usual clinical practice Surgery scheduled within about 1 month of screening (Visit 1) Expressed an interest in resuming sexual activity as soon as possible after prostatectomy Heterosexual relationship. No pre-operative erectile dysfunction: International Index of Erectile Function (IIEF) Erectile Function Domain Score score EF domain =26 at screening (Visit 1) without any therapy/devices for improvement of erections. No previous use of any therapy/devices for erectile dysfunction Historical total prostate specific antigen (PSA) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: At Screening: A)Previous or Current Medical Conditions: Any unstable medical, psychiatric, or substance abuse disorder that, in the opinion of the investigator, is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s disease) in the opinion of the Investigator would significantly impair sexual performance Primary hypoactive sexual desire Spinal cord injury Hereditary degenerative retinal disorders such as retinitis pigmentosa History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C Severe chronic or acute liver disease, including history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia Bleeding disorder Significant active peptic ulceration Any underlying cardiovascular condition including unstable angina pectoris that would preclude sexual activity History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 100 bpm) Resting hypotension (a resting systolic blood pressure of 170 mm Hg or a resting diastolic blood pressure >110 mm Hg) Symptomatic postural hypotension within 6 months of Visit 1 History of malignancy within the past 5 years (other than prostate cancer or squamous or basal cell skin cancer) Life expectancy 25% below the lower limit of normal (according to the range of the testing laboratory). Serum creatinine > 3.0 mg/dL. Elevation of AST and/or ALT >3X the ULN D) Other Exclusions: Known hypersensitivity to vardenafil, Bay 38-9456 (also known as SB-782528) or any component of the investigational medication Illiterate or are unable to understand the questionnaires or subject diary Unwilling or unable to complete the subject diary or questionnaires At Randomization: Residual prostate cancer, or requirement for radiotherapy or ADT Need for a re-exploration surgery due to hemorrhage Need for urethral catheter expected to be =3 weeks due to anastomotic fistula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary measure of efficacy in this study is: Percent of subjects with the erectile function domain score of the International Index of Erectile Function (IIEF EF domain score, calculated as the sum of scores from Questions 1-5 and 15) of >22 after 9 months of double-blind treatment plus 1-2 months of single-blind placebo wash-out, using the single blind wash-out last observation carried forward (SB wash-out LOCF) method to account for dropouts. Only observations collected during the 2 month single blind washout period will be included in the SB washout LOCF. ;Main Objective: The objective of this study is to compare the efficacy and safety of two modes of vardenafil therapy versus placebo to treat erectile dysfunction, starting within 14 days following bilateral nerve-sparing radical retropubic prostatectomy (BNSRRP). Specifically, the primary objective is to determine whether early, NIGHTLY dosing with vardenafil significantly improves recovery of erectile function after surgery as compared to placebo, and whether early PRN dosing with vardenafil also improves recovery of function as compared to placebo;Secondary Objective: To assess whether early dosing of either NIGHTLY or PRN vardenafil over 9 months, followed by 2 months of withdrawal, increases efficacy of subsequent PRN use significantly better than placebo | — |
Countries
Finland, Germany, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed