Official Title: “A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Active-Controlled Study Evaluating the Efficacy of Vardenafil Versus Tadalafil When Intercourse is Attempted Within 45 Minutes of Administration in Subjects With Erectile Dysfunction”

Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED

Study Type: Interventional

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

Surveys of sexual habits and behaviour have provided information on the 'window of opportunity' during which an ED medication should be effective. According to these surveys, the average time from thinking about having sex to doing so is less than 1 hour. Most men are unable to predict when they might have sex more than 30 minutes in advance. The aim of the present study was to compare the efficacy and tolerability of the licensed starting doses of vardenafil (10 mg) and tadalafil (10 mg) in patients with erectile issues (erectile dysfunction) who attempted sexual intercourse within 45 minutes of drug administration (i.e.

during the early window of opportunity).

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse
• Drug: Tadalafil
  • Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Active Comparator: Arm 2

Primary Measures

• Sexual Encounter Profile Question 3 (SEP-3)
  • Time Frame: 4 weeks
    Safety Issue?: No

Secondary Measures

• Sexual Encounter Profile Question 2 (SEP-2)
  • Time Frame: 4 weeks
    Safety Issue?: No
• International Index of Erectile Function
  • Time Frame: 4 weeks
    Safety Issue?: No
• Global Confidence Question (GCQ)
  • Time Frame: 4 weeks
    Safety Issue?: No
• Erection Quality Scale (EQS)
  • Time Frame: 4 weeks
    Safety Issue?: No
• General Safety
  • Time Frame: 4 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Age between 18 and 64 years
• Heterosexual males
• Erectile dysfunction for more than 6 months

Exclusion Criteria:

• Penile anatomical abnormalities
• Spinal cord injury
• History of surgical prostatectomy

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 64 Years

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 September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00663130

Study ID Number: 11333

ClinicalTrials.gov Identifier: NCT00663130

Health Authority: United States: Food and Drug Administration

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