Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT00492635
Eligibility 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 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
64 Years
Study:
NCT00492635
Study Brief:
Protocol Section:
NCT00492635