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Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse

NCT00667979 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2009-06-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Levitra (Vardenafil, BAY38-9456)

10mg and 20mg to be taken 12, 18, 24 hours prior to sexual intercourse

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-09-30
Completion
2004-12-31

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00667979 on ClinicalTrials.gov