Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome
Double-blind, Placebo Controlled, Randomized Study of Vardenafil to Determine Efficacy on Erectile Dysfunction (ED) in Men With ED and Metabolic Syndrome (ED-METABOLIC)
3 other identifiers
interventional
150
1 country
19
Brief Summary
This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2008
Shorter than P25 for phase_4
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2008
CompletedFirst Posted
Study publicly available on registry
August 20, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
June 1, 2011
CompletedNovember 16, 2015
November 1, 2015
11 months
August 19, 2008
November 26, 2010
November 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)
The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction \[ED\]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward \[LOCF\]) as calculated via an ANCOVA.
baseline and up to 8 weeks or LOCF
Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8
Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants.
Baseline and 8 weeks
Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8
Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants.
Baseline and 8 weeks
Secondary Outcomes (4)
Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)
up to 8 weeks or LOCF
Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8
Baseline and 8 weeks
Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8
Baseline and 8 weeks
Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))
week 4 and week 8
Study Arms (2)
Vardenafil (Levitra, BAY38-9456)
EXPERIMENTALVardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
Placebo
PLACEBO COMPARATORMatching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks
Interventions
Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks
Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks
Eligibility Criteria
You may qualify if:
- Stable heterosexual relationship
- History of erectile dysfunction for at least 6 months
- IIEF- EF Domain entry score (at Visit 2): \>21 points
- Documented metabolic syndrome according to the IDF (International Diabetes Foundation)
- Subjects motivated for erectile dysfunction treatment
- Documented, dated, written informed consent
You may not qualify if:
- Any underlying cardiovascular condition
- History of myocardial infarction
- Uncontrolled atrial fibrillation
- Resting hypotension
- Postural hypotension within 6 months of Visit 1
- History of congenital QT prolongation
- Bleeding disorder
- History of prostatectomy because of prostate cancer
- Hereditary degenerative retinal disorders
- History of loss of vision because of NAION (non-arteritic anterior ischemic optic neuropathy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (19)
Unknown Facility
Cham, Bavaria, 93413, Germany
Unknown Facility
Regensburg, Bavaria, 93055, Germany
Unknown Facility
Hamburg, Hamburg, 20354, Germany
Unknown Facility
Frankfurt am Main, Hesse, 60385, Germany
Unknown Facility
Marburg, Hesse, 35039, Germany
Unknown Facility
Stuhr, Lower Saxony, 28816, Germany
Unknown Facility
Bonn, North Rhine-Westphalia, 53119, Germany
Unknown Facility
Grevenbroich, North Rhine-Westphalia, 41515, Germany
Unknown Facility
Leverkusen, North Rhine-Westphalia, 51373, Germany
Unknown Facility
Mülheim, North Rhine-Westphalia, 45468, Germany
Unknown Facility
Wuppertal, North Rhine-Westphalia, 42103, Germany
Unknown Facility
Dierdorf, Rhineland-Palatinate, 56269, Germany
Unknown Facility
Koblenz, Rhineland-Palatinate, 56068, Germany
Unknown Facility
Trier, Rhineland-Palatinate, 54290, Germany
Unknown Facility
Homburg, Saarland, 66424, Germany
Unknown Facility
Dresden, Saxony, 01307, Germany
Unknown Facility
Leipzig, Saxony, 04109, Germany
Unknown Facility
Berlin, State of Berlin, 12107, Germany
Unknown Facility
Berlin, State of Berlin, 14197, Germany
Related Publications (1)
Schneider T, Gleissner J, Merfort F, Hermanns M, Beneke M, Ulbrich E. Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial. J Sex Med. 2011 Oct;8(10):2904-11. doi: 10.1111/j.1743-6109.2011.02383.x. Epub 2011 Jul 19.
PMID: 21771281RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2008
First Posted
August 20, 2008
Study Start
November 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
November 16, 2015
Results First Posted
June 1, 2011
Record last verified: 2015-11