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
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.
2 other identifiers
interventional
732
11 countries
75
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2003
Shorter than P25 for phase_3
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
April 23, 2008
CompletedFirst Posted
Study publicly available on registry
April 24, 2008
CompletedDecember 17, 2014
December 1, 2014
April 23, 2008
December 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
- 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)
First four doses with successful intercourse
Secondary Outcomes (5)
- 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).
among the first four doses
- 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.
among the first four doses
- Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration.
among the first four doses
- Other diary questions
among the first four doses
- Safety and tolerability
within the study duration
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
- years and older
You may not qualify if:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life threatening arrhythmia within the prior 6 months
- Nitrates or nitric oxide donors use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (75)
Unknown Facility
Phoenix, Arizona, 85023, United States
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Beverly Hills, California, 90212, United States
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San Bernardino, California, 92404, United States
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Aurora, Colorado, 80012, United States
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Trumbull, Connecticut, 06611, United States
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Aventura, Florida, 33180, United States
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Jacksonville, Florida, 32257, United States
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Pembroke Pines, Florida, 33024, United States
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Lawrenceville, New Jersey, 08648, United States
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New York, New York, 10016, United States
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Charlotte, North Carolina, 28209, United States
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Wilmington, North Carolina, 28401, United States
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Calgary, Alberta, T3G 3J9, Canada
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Winnipeg, Manitoba, R3T 5J3, Canada
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Saint John, New Brunswick, E2L 3J8, Canada
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Kentville, Nova Scotia, B4N 4K9, Canada
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Barrie, Ontario, L4M 4S5, Canada
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Toronto, Ontario, M4C 3E7, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Carpentras, 84200, France
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Lille, 59000, France
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Lyon, 69000, France
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Lyon, 69437, France
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Marseille, 13275, France
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Montpellier, 34000, France
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Nîmes, 30000, France
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Paris, 75015, France
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Garmisch-Partenkirchen, Bavaria, 82467, Germany
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München, Bavaria, 80333, Germany
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München, Bavaria, 81925, Germany
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Hamburg, Hamburg, 20354, Germany
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Marburg, Hesse, 35039, Germany
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Hanover, Lower Saxony, 30625, Germany
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Osnabrück, Lower Saxony, 49076, Germany
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Westerstede, Lower Saxony, 26655, Germany
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Düsseldorf, North Rhine-Westphalia, 40210, Germany
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Mönchengladbach, North Rhine-Westphalia, 41061, Germany
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Niederkassel, North Rhine-Westphalia, 53859, Germany
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Leipzig, Saxony, 04105, Germany
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Halle, Saxony-Anhalt, 06097, Germany
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Milan, 20132, Italy
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Milan, 20142, Italy
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Modena, 41100, Italy
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Napoli, 80131, Italy
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Padua, 35128, Italy
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Amsterdam, 1061 AE, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Roermond, 6043 CV, Netherlands
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The Hague, 2512 VA, Netherlands
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Utrecht, 3514 AB, Netherlands
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Moelv, 2390, Norway
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Oslo, 0272, Norway
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Sarpsborg, 1700, Norway
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Trondheim, 7006, Norway
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Warsaw, Poland, 04-749, Poland
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Kościerzyna, 83-400, Poland
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Lodz, 91-425, Poland
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Poznan, 61-701, Poland
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Warsaw, 01-059, Poland
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Wroclaw, 54-144, Poland
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Badalona, Barcelona, 08916, Spain
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Barcelona, Barcelona, 08003, Spain
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L'Hospitalet de Llobregat, Barcelona, 08907, Spain
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Galdakao, Bizkaia, 48960, Spain
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Castellon, Castellón de La Plana, 12004, Spain
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Barcelona, Catalonia, 08025, Spain
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Madrid, Madrid, 28040, Spain
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Zaragoza, Zaragoza, 50009, Spain
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Borås, 503 32, Sweden
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Gothenburg, 412 59, Sweden
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Skövde, 541 30, Sweden
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Stockholm, 171 76, Sweden
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Bristol, Avon, BS10 5NB, United Kingdom
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Bristol, Avon, BS2 8HW, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2008
First Posted
April 24, 2008
Study Start
June 1, 2003
Study Completion
November 1, 2003
Last Updated
December 17, 2014
Record last verified: 2014-12