Trial Condition(s):
Erectile Dysfunction, Metabolic Syndrome
Study of vardenafil in patients suffering from erectile dysfunction and metabolic syndrome
Bayer Identifier:
13171
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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)
Inclusion Criteria
- 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
Exclusion Criteria
- 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) - 29 Additional Exclusion Criteria
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Praxis Drs. Tim Schneider /B. Schneider Mülheim, Germany, 45468 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. F. Merfort / M. Stammen / S. van Haag Grevenbroich, Germany, 41515 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Klunder/Stephan-Odenthal Leverkusen, Germany, 51373 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. G. Böhm Bonn, Germany, 53119 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. M. Indig Trier, Germany, 54290 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. A. von Keitz Marburg, Germany, 35039 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. Böhm & Linnè Dresden, Germany, 01307 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. J. Gleißner Wuppertal, Germany, 42103 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. Netzer/Sachse Homburg, Germany, 66424 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. Popp/Hanika Regensburg, Germany, 93055 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Drs. Bickeböller & Rachel GbR Frankfurt, Germany, 60385 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. A. Rollenhagen Berlin, Germany, 12107 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urologische Gemeinschaftspraxis Berlin, Germany, 14197 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. H.-P. Fischer Koblenz, Germany, 56068 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Prof. Dr. H. Porst Hamburg, Germany, 20354 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. R. Ostwald Dierdorf, Germany, 56269 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. J. Willgerodt Leipzig, Germany, 04109 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gemeinschaftspraxis Dres. M. Brandl, M. Fichtlscherer, Cham, Germany, 93413 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxisgemeinschaft Stuhr-Brinkum Stuhr, Germany, 28816 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Double-blind, placebo controlled, randomized study of vardenafil to determine efficacy on Erectile Dysfunction (ED) in men with ED and Metabolic Syndrome (ED-METABOLIC)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Change from baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) subscore at week 8 or last observation carried forward (LOCF)Timeframe: 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 8Timeframe: Baseline and 8 weeks
- Change in percentage from baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at week 8Timeframe: Baseline and 8 weeks
Secondary Outcome
- Percentage of participants achieving "Back to Normal" Erectile Function at week 8 or last observation carried forward (LOCF)Timeframe: up to 8 weeks or LOCF
- Change in percentage from baseline in ability to obtain an erection (SEP1) at week 8Timeframe: Baseline and 8 weeks
- Change in percentage from baseline in ability to ejaculation (SEP6) at week 8Timeframe: Baseline and 8 weeks
- Number of participants who can stay on the initially provided dosage of Vardenafil (10 mg PRN (pro re nata))Timeframe: week 4 and week 8
Additional Information
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