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 - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00492635

Purpose

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.

Condition	Intervention	Phase
Erectile Dysfunction Sexual Dysfunction, Physiological	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Enrollment:	628
Study Start Date:	December 2004
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456) 9 months DAILY dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
Experimental: Arm 2	Drug: Levitra (Vardenafil, BAY38-9456) 9 months PRN dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
Placebo Comparator: Arm 3	Drug: Placebo 9 months placebo (double blind)2 months single-blind placebo wash-out period (subject only is blinded)2 months open-label PRN treatment with active medication

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492635

Show 84 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00492635 History of Changes
Other Study ID Numbers:	11336, EudraCT 2004-002172-42
Study First Received:	June 26, 2007
Last Updated:	June 2, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sexual Dysfunction, Physiological
Erectile Dysfunction
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil

Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012