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Assessment of Duration of Erection With Vardenafil 10 mg

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Levitra (Vardenafil, BAY38-9456)

Placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Vardenafil

Eligibility Criteria

18 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:- Males with erectile dysfunction- Stable heterosexual relationship Exclusion Criteria:- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months nitrate use

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Effect of vardenafil on the duration of erection

Secondary Outcome Measures

Perception of erection to be hard enough for penetration

Full Information

NCT ID

NCT00663728

First Posted

April 17, 2008

Last Updated

December 26, 2014

Sponsor

Bayer

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00663728

Brief Title

Assessment of Duration of Erection With Vardenafil 10 mg

Official Title

A Randomized, Double-blind, Crossover Study to Evaluate the Duration of Erection Following Vardenafil (10mg) Administration for Four Weeks in a Fixed Dose Regimen Compared to Placebo in Males With ED

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

April 2005 (Actual)

Study Completion Date

April 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

Collaborators

GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary

This study assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting, as compared to placebo (dummy medication with no pharmacological activity), on the duration of erection from the moment when the patient perceived his erection to be hard enough for penetration until withdrawal from the partner's vagina leading to successful completion which may or may not have included ejaculation. The patient used the stopwatch for the above assessments. The efficacy of oral ED treatments is measured by questionnaires and patient diaries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

Erectile Dysfunction, Vardenafil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

201 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Levitra (Vardenafil, BAY38-9456)

Intervention Description

10mg Vardenafil taken orally 1 hour prior to sexual intercourse

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo

Primary Outcome Measure Information:

Title

Effect of vardenafil on the duration of erection

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Perception of erection to be hard enough for penetration

Time Frame

4 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Assessment of Duration of Erection With Vardenafil 10 mg

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