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Completed

NCT Number: NCT00738400

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

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)

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Male Urogenital Diseases Mental Disorders Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Cham, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vardenafil (Levitra, BAY38-9456)

Drug

Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks

Placebo

Drug

Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks

Primary outcomes

  1. Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)

    Time frame: 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.

  2. Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8

    Time frame: 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.

  3. Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8

    Time frame: 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 outcomes

  1. Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)

    Time frame: 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')

  2. Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8

    Time frame: 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.

  3. Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8

    Time frame: 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.

  4. Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))

    Time frame: week 4 and week 8

    Number of participants with no recorded titration of Vardenafil after visit 3.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 20, 2008
Registry last updated
Nov 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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