Official Title: “A Randomized, Double Blind, Double Dummy, Parallel Group, Multi-Center Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction.”

Study to investigate the time of onset of action of 10 mg and 20 mg of Vardenafil compared to placebo in males with erectile dysfunction.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • Vardenafil 10 mg and 20 mg orally once a day as needed
• Drug: Placebo
  • Matching Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • n/a
• Placebo Comparator: Arm 2
  • n/a

Primary Measures

• Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3)
  • Time Frame: First four doses with successful intercourse
    Safety Issue?: No

Secondary Measures

• Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration as measured by Sexual Encounter Profile Question 2 (SEP 2).
  • Time Frame: among the first four doses
    Safety Issue?: No
• The erectile function (EF) domain score of the International Index of Erectile Function (IIEF) calculated as the sum of scores from Questions 1-5 and 15 at Week 4 as well as all other IIEF factor subscores.
  • Time Frame: among the first four doses
    Safety Issue?: No
• Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration.
  • Time Frame: among the first four doses
    Safety Issue?: No
• Other diary questions
  • Time Frame: among the first four doses
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: within the study duration
    Safety Issue?: Yes

Inclusion Criteria:

• Males with ED for more than 6 months according to the NIH Consensus statement(inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
• Heterosexual relationship
• 18 years and older

Exclusion Criteria:

• Primary hypoactive sexual desire
• History of myocardial infarction, stroke or life threatening arrhythmia within the prior 6 months
• Nitrates or nitric oxide donors use
• Other exclusion criteria according to the US Product Information

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00665496

Study ID Number: 100492

ClinicalTrials.gov Identifier: NCT00665496

Health Authority: United States: Food and Drug Administration

#PL#J. SEX. MED. 1 (2) 168-178 (2004) , ISSN:1743-6095

#PL#PubMed.

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