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

Completed · Phase 3 · Has a placebo group

Conditions studied: Erectile Dysfunction, Sexual Dysfunction, Physiological

In brief

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.

Key facts

Study ID

NCT00492635

Run by

Bayer

People needed

628

Starts

2004-12-01

Expected to finish

2007-09-01

Last updated by the study team

2014-10-28

Who can join

Age: 18 and older, up to 64. Sex: male. Healthy volunteers: not accepted.

You may qualify 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:
• 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

You may not qualify 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

Where it is running

• Study site — Jeffersonville, Indiana, United States
• Study site — Des Moines, Iowa, United States
• Study site — Jackson, Mississippi, United States
• Study site — Poughkeepsie, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Lancaster, Pennsylvania, United States
• Study site — Providence, Rhode Island, United States
• Study site — Spokane, Washington, United States
• Study site — Salzburg, State of Salzburg, Austria
• Study site — Graz, Styria, Austria
• Study site — Bruxelles - Brussel, Belgium
• Study site — Bruxelles - Brussel, Belgium
• Study site — Edegem, Belgium
• Study site — Hasselt, Belgium
• Study site — Leuven, Belgium
• Study site — Liège, Belgium
• Study site — Calgary, Alberta, Canada
• Study site — Edmonton, Alberta, Canada
• Study site — Barrie, Ontario, Canada
• Study site — London, Ontario, Canada
• Study site — Oakville, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Laguna Hills, California, United States

Full record on ClinicalTrials.gov

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