Clinical trial NCT00665496: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Vardenafil
Onset of action
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 732
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: - 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)
timeFrame: First four doses with successful intercourse
Secondary outcomes:
measure: - 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).
timeFrame: among the first four doses
measure: - 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.
timeFrame: among the first four doses
measure: - Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration.
timeFrame: among the first four doses
measure: - Other diary questions
timeFrame: among the first four doses
measure: - Safety and tolerability
timeFrame: within the study duration
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: San Bernardino
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Trumbull
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Lawrenceville
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Calgary
country: Canada
state: Alberta
city: Winnipeg
country: Canada
state: Manitoba
city: St. John
country: Canada
state: New Brunswick
city: Kentville
country: Canada
state: Nova Scotia
city: Barrie
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sherbrooke
country: Canada
state: Quebec
city: Carpentras
country: France
city: Lille
country: France
city: Lyon Cedex
country: France
city: Lyon
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Nimes
country: France
city: Paris
country: France
city: Garmisch-Partenkirchen
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Marburg
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Osnabrück
country: Germany
state: Niedersachsen
city: Westerstede
country: Germany
state: Niedersachsen
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Mönchengladbach
country: Germany
state: Nordrhein-Westfalen
city: Niederkassel
country: Germany
state: Nordrhein-Westfalen
city: Halle
country: Germany
state: Sachsen-Anhalt
city: Leipzig
country: Germany
state: Sachsen
city: Hamburg
country: Germany
city: Milano
country: Italy
city: Milano
country: Italy
city: Modena
country: Italy
city: Napoli
country: Italy
city: Padova
country: Italy
city: Amsterdam
country: Netherlands
city: Den Haag
country: Netherlands
city: Nijmegen
country: Netherlands
city: Roermond
country: Netherlands
city: Utrecht
country: Netherlands
city: Moelv
country: Norway
city: Oslo
country: Norway
city: Sarpsborg
country: Norway
city: Trondheim
country: Norway
city: Koscierzyna
country: Poland
city: Lodz
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Badalona
country: Spain
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Galdakao
country: Spain
state: Bizkaia
city: Barcelona
country: Spain
state: Cataluña
city: Barcelona
country: Spain
city: Castellón de la Plana
country: Spain
city: Madrid
country: Spain
city: Zaragoza
country: Spain
city: Borås
country: Sweden
city: Göteborg
country: Sweden
city: Skövde
country: Sweden
city: Stockholm
country: Sweden
city: Bristol
country: United Kingdom
state: Avon
city: Bristol
country: United Kingdom
state: Avon
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: