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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00492635
First received: June 26, 2007
Last updated: May 19, 2014
Last verified: May 2014
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 86 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00492635     History of Changes
Other Study ID Numbers: 11336, 2004-002172-42
Study First Received: June 26, 2007
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Erectile Dysfunction
Sexual and Gender Disorders
Mental Disorders
Genital Diseases, Male
Genital Diseases, Female
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 July 22, 2014