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Clinical Trials/NCT00667979
NCT00667979CompletedPhase 4

A Pilot, Randomized, Double-Blind, Placebo-Controlled, Crossover Study Evaluating the Efficacy and Safety of Vardenafil Versus Placebo Administered 12, 18 and 24 Hours Prior to Initiation of Sexual Intercourse in Subjects With ED

Bayer0 sites264 target enrollmentStarted: September 2004Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Bayer
Enrollment
264
Primary Endpoint
Sexual encounter profile Question 3

Study Overview

Brief Summary

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12, 18, and 24 hours were assessed in this pilot study to better quantify the effect of vardenafil.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Men >/= 18 years of age
  • ED >/= 6 months
  • Stable sexual relationship for > 6 months

Exclusion Criteria

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy
  • Other exclusion criteria apply according to the Summary of Product Characteristics

Arms & Interventions

Arm 1

Experimental

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

Arm 2

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Sexual encounter profile Question 3

Time Frame: 6 weeks

Secondary Outcomes

  • Safety and Tolerability(6 weeks)

Investigators

Sponsor
Bayer
Sponsor Class
Industry

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