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

Condition(s) targeted: Sexual Dysfunction; Male Erectile Dysfunction

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Bayer

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.

Official title: A Randomized, Double-Blind, Double-Dummy, Multicenter Parallel Group Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil Versus Vardenafil PRN Versus Placebo in Men Immediately After Nerve-Sparing Prostatectomy for Improving Erectile Function

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: 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

Secondary outcome: 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

Detailed description: 3 arms ( PRN, nightly, placebo):

9 months double-blind (NIGHTLY=10 mg dose which could be decreased to 5 mg if poorly tolerated, PRN=flexible dose on demand; 10 mg dose which could be decreased to 5 mg if poorly tolerated, or increased to 20 mg based on efficacy or placebo) treatment period.

2 month single-blind placebo (and no devices) wash-out period. 2 month open-label PRN period (flexible dose on demand; 10 mg dose which could be decreased to 5 mg if poorly tolerated, or increased to 20 mg based on efficacy).

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Male.

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

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Bayer Clinical Research Center, ask Contact, United Kingdom

South Coast Urological Medical Group, Laguna Hills, California 92653, United States

Metropolitan Urology Associates, PC, Jeffersonville, Indiana 47130, United States

Iowa Clinic,PC/ Iowa Urololgy, Des Moines, Iowa 50309, United States

Mississippi Urology Clinic, Jackson, Mississippi 39202, United States

Hudson Valley Urology Center, Poughkeepsie, New York 12601, United States

The Urology Group, Cincinnati, Ohio 45212-2787, United States

Columbus Urology Research, LLC, Columbus, Ohio 43214-1419, United States

Oklahoma University Health Science Center, Oklahoma City, Oklahoma 73104, United States

Urological Associates of Lancaster, Lancaster, Pennsylvania 17604, United States

University Urological Research Institute, Providence, Rhode Island 02904, United States

Office of Dr. Roger Fincher, MD, Spokane, Washington 99202, United States

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Starting date: December 2004
Last updated: June 26, 2007