Double-blind, placebo controlled, randomized study of vardenafil to determine efficacy on Erectile Dysfunction (ED) in men with ED and Metabolic Syndrome (ED-METABOLIC) - ED-METABOLIC

• Conditions: The objective of this study is to determine efficacy, tolerability and safety of vardenafil on Erectile Dysfunction (ED) in men with ED and Metabolic Syndrome.

• Registration Number: EUCTR2008-002140-41-DE
• Lead Sponsor: Bayer HealthCare AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-15
• Last Update Posted: 25 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 180

Inclusion Criteria

1) Males aged 18 up to 64 (inclusive) years.
Note: It is possible that a label change occurs during the course of this study which would affect recommendations for initial dosing of vardenafil in patients aged 65 years and older for whom the current labeling recommends a starting dose of 5 mg. If this label change is granted by the European regulatory body (EMEA), investigators will subsequently be notified that patients >64 years of age may be enrolled as well. Details will be in accordance with that possible new labeling.
2) Stable, heterosexual relationship for at least 6 months.
3) A history of erectile dysfunction (ED) for at least 6 months, defined as the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse” by the NIH Consensus Development Panel on Impotence.
4) IIEF Erectile Function Domain entry score (at Visit 2): < 21 score points.
5) Documented metabolic syndrome according to the definition of the International Diabetes Foundation (IDF)7 (Appendix 10.2): Waist circumference (to be measured at the umbilicus), > 94 cm in European, Sub-Saharan Africans, Eastern Mediterranean and Middle East (Arab) populations, > 90 cm in ethnic South Asian, Chinese, ethnic South and Central Americans, > 85 cm in Japanese, or South and Central American men. In addition, at least two of the following criteria must be met: raised TG level > 150 mg/dl, or specifc treatment for this abnormality, reduced HDL cholesterol < 40 mg/dl, or specifc treatment for this abnormality, raised blood pressure systolic BP > 130 mm Hg and/or diastolic BP > 85 mm Hg, or treatment of previously diagnosed hypertension, raised fasting plasma glucose blood glucose (FPG) > 100 mg/dl or previously diagnosed type 2 diabetes.
6) Subjects motivated to obtain treatment for erectile dysfunction.
7) Documented, dated, written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A) Previous or current medical conditions
1) Any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity according to the NIH consensus report.1
2) History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1 (= screening).
3) Uncontrolled atrial fibrillation / flutter at screening (defined as ventricular response rate = 100 bpm).
4) Resting hypotension (a resting systolic blood pressure of < 90 mm Hg) or hypertension (a resting systolic blood pressure > 170 mm Hg or a resting diastolic blood pressure > 110 mm Hg).
5) Symptomatic postural hypotension within 6 months of Visit 1.
6) History of congenital QT prolongation.
7) Bleeding disorder.
8) History of prostatectomy because of prostate cancer, including nerve-sparing techniques.
Clarification: Any surgical procedures for the treatment of Benign Prostate Hypertrophy (BPH) are permitted, with the exception of cryosurgery, cryotherapy or cryo-ablation.
9) Hereditary degenerative retinal disorders such as retinitis pigmentosa.
10) History of loss of vision because of NAION, temporary or permanent loss of vision, including unilateral loss of vision.
11) Presence of penile anatomical abnormalities/deviations, e.g. due to Peyronie’s disease which, in the investigator’s opinion would significantly impair sexual performance.
12) Clinically significant chronic hematological disease which may lead to priapism, such as sickle cell anaemia, multiple myeloma, and leukaemia.
13) Primary hypoactive sexual desire.
14) Spinal cord injury.
15) Active peptic ulceration.
16) History of malignancy within the past 5 years (other than squamous or basal cell skin cancer).
17) Severe chronic or acute liver disease, history of moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment.
18) History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C.
19) History of documented elevation of AST and/or ALT > 3 times the upper limit of the normal range (laboratory-specific).
20) Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the investigator is likely to affect the subject's ability to complete the study or precludes the subject’s participation in the study.
21) Patients with evident clinical signs of hypogonadism and/or documented total plasma testosterone < 12 nmol/L.
22) Subjects with known renal insufficiency defined according to the following thresholds of documented laboratory data: Serum creatinine > 3.0 mg/dL and/or creatinine clearance (calculated) < 30.0 ml/min.

B) Concomitant medications
1) Subjects who are taking nitrates or nitric oxide donors.
2) Subjects who are exposed to androgens irrespective of their mode of administration.
3) Subjects who are taking anti-androgens.
4) Subjects who are taking alpha-blockers.
5) Subjects who are taking one or more of the following potent inhibitors of cytochrome P450 3A4: HIV protease inhibitors such as ritonavir or indinavir, the anti-mycotic agents itraconazole or ketoconazole (topical forms are allowed), and the macrolide antibiotics clarithromycin and erythromycin.
6) Subjects who are taking medications known to prolong the QT interval, such as Type Ia and Type 3 anti-arrhythmic drugs.
7) Subjects who have received any investigational drug (including placebo) within 30 days of Visit 1.
8) Use of any treatment for ED during the entire study (i.e. subsequent to Visit 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to determine efficacy, tolerability and safety of vardenafil on Erectile Dysfunction (ED) in men with ED and Metabolic Syndrome.;Secondary Objective: To explore the rate of patients who require the highest dosage based upon the expectation that most men can stay on 10 mg PRN according to pre-defined criteria for dose titration (secondary variable).;Primary end point(s):