Phase 4 N=150 Randomized Double-blind Treatment

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

Erectile Dysfunction · Metabolic Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00738400 ↗

Enrolled (actual)

150

Serious AEs

0.0%

Results posted

Jun 2011

Primary outcome: 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) — 20.96; 14.20 Scores on a scale — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Vardenafil (Levitra, BAY38-9456) (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: Male
Sponsor: Bayer
Primary completion: Oct 2009

Outcome Measures

Outcome	Result	p-value
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)	20.96; 14.20	<0.0001 sig
PRIMARY Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8	73.50; 52.79	<0.0001 sig
PRIMARY Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8	53.15; 27.00	<0.0001 sig
SECONDARY Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)	35; 10	0.0004 sig
SECONDARY Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8	91.36; 75.79	0.0003 sig
SECONDARY Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8	71.29; 43.96	<0.0001 sig
SECONDARY Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))	28; 13	—

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)

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00738400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.