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: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Vardenafil Dihydrochloride

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