Erectile Dysfunction, Sexual Dysfunction, Physiological

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 without any therapy/devices for improvement of erections
- No perforation of the prostate capsule by tumor
At Randomization:
Before being randomized subjects must still be meeting all Screening , as well as the following criteria:
- bilateral nerve-sparing during the retropubic prostatectomy documented on the operating report
- BNSRRP occurred within approximately 1 month post screening (Visit 1)
- No perforation of the prostate capsule by tumor:
No positive tumor margins confirmed after surgery: =T2 stage on pathology report from the surgery

- Subjects who are taking nitrates or nitric oxide donors
- Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin
- Known hypersensitivity to Vardenafil
- Presence of significant penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease)
- History of retinitis pigmentosa
- Unstable angina pectoris
- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- Severe chronic or acute liver disease
- Symptomatic postural hypotension in the past 6 months
- NYHA Class III or IV heart failure
- Life expectancy <3 years
- Clinical diagnosis of significant untreated sleep apnea or working night shifts (e.g. 23:00h to 7:00 h)
- Anti-androgens use
- Residual prostate cancer, or requirement for radiotherapy or ADT after surgery