Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving ED
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
18–64
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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:
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
You may not be if
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
Clareo Health | Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-sparing Prostatectomy for Improving ED
