- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00681772
Evaluation of the Safety and Efficacy of Vardenafil in Subjects With Erectile Dysfunction
December 10, 2014 updated by: Bayer
Open-label, Multi-centre, Study to Investigate the Safety, Tolerability and Efficacy of Flexible Doses of Vardenafil Given on Demand in Males With Erectile Dysfunction
Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance.
An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable.
The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
333
Phase
- Phase 4
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:
- Men >/= 18 years of age,
- ED 6 months or longer
- 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
- 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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
|
5mg, 10mg or 20mg taken 1 hours before sexual intercourse
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
International Index of Erectile Function - Erectile Function Domain
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability
Time Frame: 12 weeks
|
12 weeks
|
Global Assessment Question
Time Frame: 12 weeks
|
12 weeks
|
Sexual Encounter Profile Question 2 and 3
Time Frame: 12 weeks
|
12 weeks
|
Other diary based variables
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
March 1, 2003
Study Completion (Actual)
November 1, 2003
Study Registration Dates
First Submitted
April 18, 2008
First Submitted That Met QC Criteria
May 20, 2008
First Posted (Estimate)
May 21, 2008
Study Record Updates
Last Update Posted (Estimate)
December 11, 2014
Last Update Submitted That Met QC Criteria
December 10, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100541
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.
Clinical Trials on Erectile Dysfunction
-
University of VirginiaActive, not recruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Erectile Dysfunction Due to General Medical Condition | Erectile Dysfunction Due to Arterial InsufficiencyUnited States
-
Cairo UniversityRecruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Simple Prostatectomy | Erectile Dysfunction With Diabetes Mellitus | Erectile Dysfunction Due to Arterial Disease | Erectile Dysfunction Due to Injury | Erectile Dysfunction Due to Neuropathy and other conditionsEgypt
-
University of BaghdadCompletedSexual Dysfunction | Erectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Sexual Abstinence | Erectile Dysfunction With Diabetes Mellitus | Sexual Desire Disorder | Erectile Dysfunction Following Cryotherapy | Erectile Dysfunction... and other conditionsIraq
-
BayerCompletedSexual Dysfunction | Male Erectile DysfunctionBelgium, Italy, France, Germany, Spain, Netherlands, South Africa
-
Cairo UniversityCompletedVasculogenic Erectile DysfunctionEgypt
-
InitiaTerminatedVasculogenic Erectile DysfunctionIsrael
-
InitiaCompletedVasculogenic Erectile DysfunctionIsrael
-
InitiaCompletedVasculogenic Erectile DysfunctionCzech Republic, Lithuania, Netherlands, Palestinian Territories, Occupied
-
Rexahn Pharmaceuticals, Inc.CompletedErectile Dysfunction (ED)United States
-
SK Chemicals Co., Ltd.TerminatedMale Erectile Dysfunction
Clinical Trials on Levitra (Vardenafil, BAY38-9456)
-
BayerCompleted
-
BayerGlaxoSmithKlineCompleted
-
BayerCompletedErectile DysfunctionBelgium, Finland, Germany, France, Denmark, United Kingdom, Spain
-
BayerCompletedErectile Dysfunction
-
BayerCompletedDepression | Erectile DysfunctionItaly, Spain, France, United States, Canada
-
BayerCompletedErectile DysfunctionHong Kong, Malaysia, Singapore, Thailand, Philippines, Indonesia
-
BayerGlaxoSmithKlineCompletedErectile DysfunctionUnited States, Canada
-
BayerGlaxoSmithKlineCompleted
-
BayerCompletedDiabetes Mellitus | Erectile Dysfunction