Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Double-blind, Placebo Controlled, Randomized Study of Vardenafil to Determine Efficacy on Erectile Dysfunction (ED) in Men With ED and Metabolic Syndrome (ED-METABOLIC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738400
• Other study ID #: 13171
• Secondary ID: 2008-002140-41ED
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2008
• Last updated: November 12, 2015
• Start date: November 2008
• Est. completion date: October 2009

Study information

• Verified date: November 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Vardenafil (Levitra, BAY38-9456)
Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks
• Placebo
Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

References & 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): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)	Responders: percentage of participants achieving an IIEF-EF score >25.(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 ED')	up to 8 weeks or LOCF	No
Secondary	Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8	Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants.	Baseline and 8 weeks	No
Secondary	Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8	Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants.	Baseline and 8 weeks	No
Secondary	Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))	Number of participants with no recorded titration of Vardenafil after visit 3.	week 4 and week 8	No

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