Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks
The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of...
Brief Summary
Official Title: “A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen Compared to Placebo in Subjects With Erectile Dysfunction”
The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Levitra (Vardenafil, BAY38-9456)
- 5mg, 10mg or 20mg taken 8 hours before sexual 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
- Per-patient success rates based on Sexual Encounter Profile, Question 3
- Time Frame: 10 weeks
Safety Issue?: No
- Time Frame: 10 weeks
Secondary Measures
- Per-subject success rates based on Sexual Encounter Profile, Question 2
- Time Frame: 10 weeks
Safety Issue?: No
- Time Frame: 10 weeks
- International Index of Erectile Function- Erectile Function domain score
- Time Frame: 10 weeks
Safety Issue?: No
- Time Frame: 10 weeks
- Global Assessment Question (GAQ)
- Time Frame: 10 weeks
Safety Issue?: No
- Time Frame: 10 weeks
- Safety and tolerability
- Time Frame: 10 weeks
Safety Issue?: Yes
- Time Frame: 10 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH
- Consensus statement,
- History of unresponsiveness to sildenafil
- Stable sexual relationship for > 6 month.
Exclusion Criteria:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
- Nitrate therapy.
Gender Eligibility for this Clinical Trial: Male
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Bayer Industry
Overall Clinical Trial Officials and Contacts
Bayer Study Director Study Director Bayer
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00682019
Study ID Number: 100493
ClinicalTrials.gov Identifier: NCT00682019
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00682019
