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

Condition(s) targeted: Erectile Dysfunction

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Study to investigate the time of onset of action of 10 mg and 20 mg of Vardenafil compared to placebo in males with erectile dysfunction.

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.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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)

Secondary outcome:

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).

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.

Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration.

Other diary questions

Safety and tolerability

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

NIMES 30000, France

LYON 69000, France

CARPENTRAS 84200, France

LYON CEDEX 69437, France

MARSEILLE 13275, France

LILLE 59000, France

Milano 20132, Italy

Padova 35128, Italy

Milano 20142, Italy

NIJMEGEN 6525 GA, Netherlands

UTRECHT 3514 AB, Netherlands

DEN HAAG 2512 VA, Netherlands

ROERMOND 6043 CV, Netherlands

AMSTERDAM 1061 AE, Netherlands

Oslo 0272, Norway

Moelv 2390, Norway

Trondheim 7030, Norway

Sarpsborg 1700, Norway

Lodz 91-425, Poland

Warszawa 01-059, Poland

Warszawa 04-749, Poland

Koscierzyna 83-400, Poland

Poznan 61-701, Poland

Castellón de la Plana 12004, Spain

Madrid 28040, Spain

Zaragoza 50009, Spain

Göteborg 412 59, Sweden

Stockholm 171 76, Sweden

Skövde 541 30, Sweden

Borås 503 32, Sweden

Phoenix, Arizona 85023, United States

Bristol, Avon BS2 8HW, United Kingdom

Bristol, Avon BS10 5NB, United Kingdom

L'Hospitalet de Llobregat, Barcelona 08907, Spain

München, Bayern / 280 81925, Germany

München, Bayern / 280 80333, Germany

San Bernardino, California 92404, United States

Beverly Hills, California 90212, United States

Aurora, Colorado 80012, United States

Trumbull, Connecticut 06611, United States

Aventura, Florida 33180, United States

Jacksonville, Florida 32257, United States

Pembroke Pines, Florida 33024, United States

Hamburg, Hamburg / 287 20354, Germany

Marburg, Hessen / 307 35039, Germany

Winnipeg, Manitoba R3T 5J3, Canada

St. John, New Brunswick E2L 3J8, Canada

Lawrenceville, New Jersey 08648, United States

New York, New York 10016, United States

Hannover, Niedersachsen / 291 30625, Germany

Osnabrück, Niedersachsen / 293 49076, Germany

Westerstede, Niedersachsen / 293 26655, Germany

Düsseldorf, Nordrhein-Westfalen / 296 40210, Germany

Niederkassel, Nordrhein-Westfalen / 336 53859, Germany

Mönchengladbach, Nordrhein-Westfalen / 618 41061, Germany

Charlotte, North Carolina 28209, United States

Wilmington, North Carolina 28412, United States

Kentville, Nova Scotia B4N 4K9, Canada

Barrie, Ontario L4M 4S5, Canada

Toronto, Ontario M4C 3E7, Canada

Sherbrooke, Quebec J1H 5N4, Canada

Montreal, Quebec H1T 2M4, Canada

Leipzig, Sachsen / 313 04105, Germany

Halle, Sachsen-Anhalt / 311 06097, Germany

#PL#J. SEX. MED. 1 (2) 168-178 (2004) , ISSN:1743-6095

#PL#PubMed.

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Starting date: June 2003
Ending date: November 2003
Last updated: April 23, 2008