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Assessment of Duration of Erection With Vardenafil 10 mg

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ClinicalTrials.gov Identifier: NCT00663728
Recruitment Status : Completed
First Posted : April 22, 2008
Last Update Posted : December 30, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Bayer

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 Type : Interventional  (Clinical Trial)
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 : September 2004
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005


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



Primary Outcome Measures :
  1. Effect of vardenafil on the duration of erection [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Perception of erection to be hard enough for penetration [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663728


Sponsors and Collaborators
Bayer
GlaxoSmithKline
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00663728     History of Changes
Other Study ID Numbers: 11575
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by Bayer:
Erectile Dysfunction
Vardenafil

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents