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
Phase 3
Completed
- Conditions
- Erectile DysfunctionSexual Dysfunction, Physiological
- Interventions
- Drug: Placebo
- Registration Number
- NCT00492635
- Lead Sponsor
- Bayer
- Brief Summary
A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability and if it can help in recovery of erections after a nerve sparing radical prostatectomy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 628
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 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 Inclusion Criteria, 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 3 Placebo - Arm 2 Levitra (Vardenafil, BAY38-9456) - Arm 1 Levitra (Vardenafil, BAY38-9456) -
- Primary Outcome Measures
Name Time Method 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 9 months
- Secondary Outcome Measures
Name Time Method 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 13 months