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

Phase 4

Completed

• Conditions: Metabolic Syndrome; Erectile Dysfunction
• Interventions: Drug: Vardenafil (Levitra, BAY38-9456); Drug: Placebo

• Registration Number: NCT00738400
• Lead Sponsor: Bayer

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)

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Study Start: 2008-11
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2010-11-26
• Results First Submitted QC: 2011-04-29
• Results First Posted: 2011-06-01
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-12
• Last Update Posted: 2015-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vardenafil (Levitra, BAY38-9456)	Vardenafil (Levitra, BAY38-9456)	Vardenafil 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	Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)	baseline and up to 8 weeks or 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.
Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8	Baseline and 8 weeks	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.
Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8	Baseline and 8 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8	Baseline and 8 weeks	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.
Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8	Baseline and 8 weeks	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.
Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)	up to 8 weeks or 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')
Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))	week 4 and week 8	Number of participants with no recorded titration of Vardenafil after visit 3.