Erectile Dysfunction Classification code 10061461
Conditions
Interventions
Trade Name: Levitra 10 mg Filmtabletten
Product Name: Levitra
Product Code: Bay 38-9456
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Vardenafil-HCL
CAS Number: 224785-91-5
Current Spon
Sponsors
Bayer Healthcare AG
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Males 18-64 years of age Mild or mild to moderate ED (defined as >15 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A) Previous or Current Medical Conditions 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 Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie’s disease) in the opinion of the Investigator would significantly impair sexual performance Primary hypoactive sexual desire Spinal cord injury History of glaucoma History of surgical prostatectomy (transurethral intervention not excluded) Hereditary degenerative retinal disorders such as retinitis pigmentosa History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C Known severe chronic or acute liver disease, including history of moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia, multiple myeloma or leukemia Clinically significant bleeding disorder Significant active peptic ulceration Any underlying cardiovascular condition including e.g. unstable angina pectoris or ventricular failure NYHA stages III or IV, that would preclude sexual activity; symptomatic angina pectoris History of myocardial infarction, stroke, or life-threatening arrhythmia within the prior 6 months Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 100 bpm) Resting hypotension (a resting systolic blood pressure of 170 mmHg (systolic) or > 110 mmHg (diastolic) irrespective of a patient having been classified as hypertensive or not. Symptomatic postural hypotension within six months of Visit 1 History of malignancy within the past 5 years (other than squamous or basal cell skin cancer) Life expectancy 25% below the lower limit of normal (according to the range of the testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to explore the prophylactic (prophylaxis of deterioration) or curative efficacy and safety of long-term (12 and 24 weeks) daily administration of vardenafil therapy (administration at night) versus vardenafil PRN on erectile dysfunction in men with mild or mild to moderate, predominantly organic ED. ;Secondary Objective: The secondary objective is to assess descriptively whether this estimated treatment effect depends upon the duration of daily dosing of the PDE-5 inhibitor. Furthermore, it shall be assessed descriptively whether or not the immediate and the possible sustainable effect on ED corresponds with an effect on patients' satisfaction by using a validated ED-specific questionnaire (TSS).;Primary end point(s): Primary efficacy variable will be the Erectile Dysfunction change score from baseline of the International Index of Erectile Function (IIEF-EF) as observed in week 24-28 (treatment ’24 weeks nightly’), and week 12-16 (treatment ’12 weeks nightly’), and week 24-28 (treatment ’24 weeks PRN’). | — |
Countries
Germany
Outcome results
None listed