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 - Tabular View

Tracking Information

First Received Date ^ICMJE

June 26, 2007

Last Updated Date

June 26, 2009

Start Date ^ICMJE

December 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00492635 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Erectile Dysfunction
Sexual Dysfunction, Physiological

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

630

Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Austria, Belgium, Canada, Finland, France, Germany, Italy, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00492635

Responsible Party

Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.

Study ID Numbers ^ICMJE

11336, EudraCT 2004-002172-42

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP