Erectile Dysfunction
Conditions
Keywords
Erectile Dysfunction, Vardenafil, Onset of action
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.
Interventions
DRUGLevitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg and 20 mg orally once a day as needed
DRUGPlacebo
Matching Placebo
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - 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
| Measure | Time frame |
|---|---|
| - 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 |
Countries
Canada, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden, United Kingdom, United States
Outcome results
None listed