Assess Efficacy of Vardenafil 10mg in Erectile Dysfunction Within Intake of 6 Hours
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)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
Assess efficacy of vardenafil within 6 hours after intake
Clinical Details
Official title: An Open-Label, Multicenter Study to Assess Safety, Tolerability, Efficacy and Impact on Quality of Life of Vardenafil 10mg in Patients With Erectile Dysfunction Within a Time Window of up to 6 Hours After Intake of Study Drug
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake
Secondary outcome: International Index of Erectile FunctionGlobal Assessment Question (GAQ) Other diary responses General Safety
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Age: 18 years and older
- 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: January 2003
Ending date: October 2003
Last updated: April 27, 2008
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