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

Sponsor:	Bayer
Collaborator:	GlaxoSmithKline
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00667979

Purpose

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.

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil Vardenafil dihydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Sexual encounter profile Question 3 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and Tolerability [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	264
Study Start Date:	September 2004
Study Completion Date:	December 2004

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456) 10mg and 20mg to be taken 12, 18, 24 hours prior to sexual intercourse
Placebo Comparator: Arm 2	Drug: Placebo Matching placebo

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00667979

Sponsors and Collaborators

Bayer

GlaxoSmithKline

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Affairs Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00667979 History of Changes
Other Study ID Numbers:	11586
Study First Received:	April 24, 2008
Last Updated:	June 29, 2009
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Bayer:

Erectile Dysfunction
Vardenafil

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012