Assessment of Duration of Erection With Vardenafil 10 mg
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Direct, Study Director, Affiliation: Bayer
Summary
Assessment of duration of erection with vardenafil 10 mg
Clinical Details
Official title: A Randomized, Double-Blind, Crossover Study to Evaluate the Duration of Erection Following Vardenafil (10mg) Administration for Four Weeks in a Fixed Dose Regimen Compared to Placebo in Males With ED
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Effect of vardenafil on the duration of erection
Secondary outcome: Perception of erection to be hard enough for penetration
Detailed description:
The main characteristics of ED are the inability to achieve and/or maintain an erection which
would allow the patient to insert his penis into his partner's vagina and more importantly to
maintain the erection long enough for a successful completion of the intercourse. This study
assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting, as compared
to placebo (dummy medication with no pharmacological activity), on the duration of erection
from the moment when the patient perceived his erection to be hard enough for penetration
until withdrawal from the partner's vagina leading to successful completion which may or may
not have included ejaculation. The patient used the stopwatch for the above assessments. The
efficacy of oral ED treatments is measured by questionnaires and patient diaries.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Age: 18 to 64 years
- Males with erectile dysfunction
- Stable heterosexual relationship
Exclusion Criteria:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within the
prior 6 months nitrate use
Locations and Contacts
Additional Information
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Starting date: September 2004
Ending date: April 2005
Last updated: April 17, 2008
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