Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia
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: Vardenafil (Levitra, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456)
compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)
Clinical Details
Official title: Randomised, Double Blind, Placebo Controlled, Parallel Group, Multi-Centre, Multinational Study to Evaluate the Efficacy and Tolerability of Vardenafil (BAY 38-9456) in Treatment of Male Erectile Dysfunction in Asia
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)
Secondary outcome: Global Assessment QuestionOther diary responses Safety and tolerability
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Age: 20 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
- Other exclusion criteria apply according to the Summary of Product Characteristics
Locations and Contacts
Hong Kong, Hong Kong
Jakarta 10430, Indonesia
Kuala Lumpur, Malaysia
Kuala Lumpur 51200, Malaysia
Manila, Philippines
Manila 150, Philippines
Singapore 119074, Singapore
Singapore 169608, Singapore
Singapore 529889, Singapore
Bangkok, Thailand
Bangkok 10700, Thailand
Petaling Jaya, Salangor 47500, Malaysia
Kuching, Sarawak, Malaysia
Additional Information
Click here to find results for studies related to marketed products Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA
Starting date: March 2003
Ending date: April 2004
Last updated: April 28, 2008
|
