Assessment of Duration of Erection With Vardenafil 10 mg

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00663728
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 201
• Arms: 2
• Duration (Months): 7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456); Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2004
• Actual Primary Completion Date: Apr 1, 2005
• Actual Study Completion Date: Apr 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456); 10mg Vardenafil taken orally 1 hour prior to sexual intercourse
Placebo Comparator: Arm 2	Drug: Placebo; Matching placebo

Outcome Measures

Primary Outcome Measures

1. Effect of vardenafil on the duration of erection [4 weeks]

Secondary Outcome Measures

1. Perception of erection to be hard enough for penetration [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bayer
• GlaxoSmithKline

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT00663728
• Other Study ID Numbers: 11575
• First Posted: Apr 22, 2008
• Last Update Posted: Dec 30, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Bayer: Erectile Dysfunction; Vardenafil
• Additional relevant MeSH terms: Erectile Dysfunction; Vardenafil Dihydrochloride

Study Results

No Results Posted as of Dec 30, 2014