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
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
628 participants in 3 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal