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...
Date First Received: April 25, 2008
Last Updated: April 28, 2008
Verified by: Bayer, April 2008
Clinical Trial Phase: Phase 4 | Start Date: March 2003
Overall Status: Completed
Estimated Enrollment: 413
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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)
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Vardenafil (Levitra, BAY38-9456)
- Vardenafil 10 mg orally on demand prior to intercourse
- Drug: Placebo
- Matching placebo
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Arm 1
- Placebo Comparator: Arm 2
Outcome Measures for this Clinical Trial
Primary Measures
- International Index of Erectile Function (IIEF) Questionnaire and Sexual Encounter Profile question 2 (SEP 2) and Sexual Encounter Profile question 3 (SEP 3)
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
Secondary Measures
- Global Assessment Question
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
- Other diary responses
- Time Frame: 12 weeks
Safety Issue?: No
- Time Frame: 12 weeks
- Safety and tolerability
- Time Frame: 12 weeks
Safety Issue?: Yes
- Time Frame: 12 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Bayer
Overall Clinical Trial Officials and Contacts
Bayer Study Director Study Director Bayer
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00668135
Study ID Number: 10657
ClinicalTrials.gov Identifier: NCT00668135
Health Authority: Malaysia: Ministry of Health
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
Clinical Trials Authorship and Review
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
