BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction - Full Text View

Sponsor:	Bayer
Collaborator:	GlaxoSmithKline
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00665054

Purpose

Purpose of the study is:

To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo
To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Multi-Centre, Randomized, Double-Blind, Parallel, Placebo-Controlled Clinical Study to Assess the Efficacy and Tolerability of Vardenafil and Its Influence on Self-Esteem and Self Confidence in Subjects With Erectile Dysfunction.

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

LOCF improved compared to baseline GAQ results at the end of the study [ Time Frame: baseline versus visit 2 visit 5 or premature termination visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

IIEF scores [ Time Frame: visits 3, 4 and 5 ] [ Designated as safety issue: No ]
OF, SD, IS scores in IIEF Questionnaire [ Time Frame: visits 2, 3, 4, 5 or at premature termination visit ] [ Designated as safety issue: No ]
Scores of all individual questions on IIEF questionnaire [ Time Frame: visits 2, 3, 4, 5 or at premature termination visit ] [ Designated as safety issue: No ]
Subject's diary response [ Time Frame: baseline and after randomization per visit period ] [ Designated as safety issue: No ]
SSES-E scores [ Time Frame: visits 2 and 5 or premature termination visit ] [ Designated as safety issue: No ]
Summary score from the responses to SSES-E [ Time Frame: visits 2 and 5 or premature termination visit ] [ Designated as safety issue: No ]
Response scores and summary score from the responses to the SF-36 [ Time Frame: visits 2 and 5 or premature termination visit ] [ Designated as safety issue: No ]

Enrollment:	150
Study Start Date:	August 2004
Study Completion Date:	August 2005

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) 5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity
Arm 2: Placebo Comparator	Drug: Placebo Matching placebo tablets orally prior to sexual activity

Eligibility

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

Criteria

Inclusion Criteria:

Men with heterosexual relationships aged 18 - 64 years suffering from ED for more than 6 months according to the NIH Consensus Statement (i.e. inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
At least 4 attempts at sexual intercourse (according to the question in the subject diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary.

Exclusion Criteria:

Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease) that in the investigator's opinion would significantly impair sexual performance.
Primary hypoactive sexual desire.
Spinal cord injury
History of surgical prostatectomy (transurethral interventions not excluded).
Unstable angina pectoris.
History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate >100 BPM).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665054

Locations

Turkey

Izmir, Turkey, 35340

Adana, Turkey, 01330

Ankara, Turkey, 06500

Istanbul, Turkey, 34098

Antalya, Turkey, 07003

Ankara, Turkey, 06100

Samsun, Turkey, 55139

Istanbul, Turkey, 34662

Sponsors and Collaborators

Bayer

GlaxoSmithKline

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Medical Affairs Therapeutic Area Head )
Study ID Numbers:	11382
Study First Received:	April 18, 2008
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00665054 History of Changes
Health Authority:	Turkey: Ethics Committee; Turkey: Ministry of Health

Keywords provided by Bayer:

Vardenafil
Erectile dysfunction
SSES-E (sexual self-efficacy scale - erectile function)

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action
Mental Disorders

Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010