A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00665496

Purpose

This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double Blind, Double Dummy, Parallel Group, Multi-Center Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males 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:

- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3) [ Time Frame: First four doses with successful intercourse ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration as measured by Sexual Encounter Profile Question 2 (SEP 2). [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- The erectile function (EF) domain score of the International Index of Erectile Function (IIEF) calculated as the sum of scores from Questions 1-5 and 15 at Week 4 as well as all other IIEF factor subscores. [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration. [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- Other diary questions [ Time Frame: among the first four doses ] [ Designated as safety issue: No ]
- Safety and tolerability [ Time Frame: within the study duration ] [ Designated as safety issue: Yes ]

Enrollment:	870
Study Start Date:	June 2003
Study Completion Date:	November 2003

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) Vardenafil 10 mg and 20 mg orally once a day as needed
Arm 2: Placebo Comparator	Drug: Placebo Matching Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males with ED for more than 6 months according to the NIH Consensus statement(inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
Heterosexual relationship
18 years and older

Exclusion Criteria:

Primary hypoactive sexual desire
History of myocardial infarction, stroke or life threatening arrhythmia within the prior 6 months
Nitrates or nitric oxide donors use
Other exclusion criteria according to the US Product Information

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665496

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Locations

United States, Arizona

Phoenix, Arizona, United States, 85023
United States, California

San Bernardino, California, United States, 92404

Beverly Hills, California, United States, 90212
United States, Colorado

Aurora, Colorado, United States, 80012
United States, Connecticut

Trumbull, Connecticut, United States, 06611
United States, Florida

Aventura, Florida, United States, 33180

Jacksonville, Florida, United States, 32257

Pembroke Pines, Florida, United States, 33024
United States, New Jersey

Lawrenceville, New Jersey, United States, 08648
United States, New York

New York, New York, United States, 10016
United States, North Carolina

Charlotte, North Carolina, United States, 28209

Wilmington, North Carolina, United States, 28401
Canada, Alberta

Calgary, Alberta, Canada, T3G 3J9
Canada, Manitoba

Winnipeg, Manitoba, Canada, R3T 5J3
Canada, New Brunswick

St. John, New Brunswick, Canada, E2L 3J8
Canada, Nova Scotia

Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario

Barrie, Ontario, Canada, L4M 4S5

Toronto, Ontario, Canada, M4C 3E7
Canada, Quebec

Sherbrooke, Quebec, Canada, J1H 5N4

Montreal, Quebec, Canada, H1T 2M4
France

NIMES, France, 30000

LYON, France, 69000

CARPENTRAS, France, 84200

LYON CEDEX, France, 69437

MARSEILLE, France, 13275

LILLE, France, 59000

PARIS, France, 75015

MONTPELLIER, France, 34000
Germany

Hamburg, Germany, 20354
Germany, Bayern

München, Bayern, Germany, 81925

München, Bayern, Germany, 80333

Garmisch-Partenkirchen, Bayern, Germany, 82467
Germany, Hessen

Marburg, Hessen, Germany, 35039
Germany, Niedersachsen

Osnabrück, Niedersachsen, Germany, 49076

Hannover, Niedersachsen, Germany, 30625

Westerstede, Niedersachsen, Germany, 26655
Germany, Nordrhein-Westfalen

Düsseldorf, Nordrhein-Westfalen, Germany, 40210

Mönchengladbach, Nordrhein-Westfalen, Germany, 41061

Niederkassel, Nordrhein-Westfalen, Germany, 53859
Germany, Sachsen

Leipzig, Sachsen, Germany, 04105
Germany, Sachsen-Anhalt

Halle, Sachsen-Anhalt, Germany, 06097
Italy

Milano, Italy, 20132

Napoli, Italy, 80131

Modena, Italy, 41100

Padova, Italy, 35128

Milano, Italy, 20142
Netherlands

NIJMEGEN, Netherlands, 6525 GA

NIJMEGEN, Netherlands, 6525 GA

UTRECHT, Netherlands, 3514 AB

DEN HAAG, Netherlands, 2512 VA

ROERMOND, Netherlands, 6043 CV

AMSTERDAM, Netherlands, 1061 AE
Norway

Oslo, Norway, 0272

Moelv, Norway, 2390

Trondheim, Norway, 7006

Sarpsborg, Norway, 1700
Poland

Lodz, Poland, 91-425

Warszawa, Poland, 01-059

Warszawa, Poland, 04-749

Koscierzyna, Poland, 83-400

Poznan, Poland, 61-701

Wroclaw, Poland, 54-144
Spain

Barcelona, Spain, 08003

Castellón de la Plana, Spain, 12004

Madrid, Spain, 28040

Zaragoza, Spain, 50009
Spain, Barcelona

L'Hospitalet de Llobregat, Barcelona, Spain, 08907

Badalona, Barcelona, Spain, 08916
Spain, Bizkaia

Galdakao, Bizkaia, Spain, 48960
Spain, Cataluña

Barcelona, Cataluña, Spain, 08025
Sweden

Göteborg, Sweden, 412 59

Stockholm, Sweden, 171 76

Skövde, Sweden, 541 30

Borås, Sweden, 503 32
United Kingdom, Avon

Bristol, Avon, United Kingdom, BS2 8HW

Bristol, Avon, United Kingdom, BS10 5NB

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

#PL#J. SEX. MED. 1 (2) 168-178 (2004) , ISSN:1743-6095 This link exits the ClinicalTrials.gov site

#PL#PubMed. This link exits the ClinicalTrials.gov site

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No publications provided

Responsible Party:	Bayer Healthcare AG ( Therapeutic Area Head )
Study ID Numbers:	100492, ONTIME
Study First Received:	April 23, 2008
Last Updated:	June 12, 2009
ClinicalTrials.gov Identifier:	NCT00665496 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bayer:

Erectile Dysfunction
Vardenafil
Onset of action

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 November 30, 2009