- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00661297
Study Evaluating the Efficacy, Safety, and Reliability of Vardenafil
December 1, 2014 updated by: Bayer
A Randomised, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy, Safety, and Reliability of 10mg Vardenafil Administered for 12 Weeks Compared to Placebo in Subjects With Erectile Dysfunction
Study to investigate the efficacy and safety of Vardenafil
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
523
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Heterosexual males
- >/= 18 years old with ED for more than six months
- Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation
Exclusion Criteria:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
- Nitrate therapy
- Other exclusion criteria apply according to the Summary of Product Characteristics
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
|
10 mg Vardenafil to be taken 1 h prior to sexual attempt
|
Placebo Comparator: Arm 2
|
Matching placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sexual Encounter Profile question 2 (SEP 2)
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
International Index of Erectile Function (IIEF) - EF (Erectile Function) domain
Time Frame: 12 weeks
|
12 weeks
|
Safety and Tolerability
Time Frame: 12 weeks
|
12 weeks
|
Sexual Encounter Profile question 3 (SEP 3)
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Study Completion (Actual)
January 1, 2004
Study Registration Dates
First Submitted
April 15, 2008
First Submitted That Met QC Criteria
April 17, 2008
First Posted (Estimate)
April 18, 2008
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
December 1, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100536
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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