A prospective, randomized, double-blind, double-dummy, placebo- and active controlled, multicenter study assessing the efficacy and safety of the combination BAY 60 4552 / vardenafil compared to vardenafil (20 mg) for the treatment of erectile dysfunction not sufficiently responsive to standard therapy with PDE5 inhibitors - IMP 14694

Bayer0 sites30 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sponsor

•\-Written informed consent signed before any study\-specific procedure
•\-History of ED for at least 6 months prior to screening, defined as the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse;(1\) the diagnosis of ED has to be confirmed by a physician
•\-Stable, heterosexual relationship for at least 6 months prior to screening
•\-Aged 18 to 64 years (inclusive) at the first screening examination
•\-Highly motivated to obtain treatment for ED
•\-History of previous use of at least 1 marketed PDE5 inhibitor and insufficient therapeutic efficacy despite use of the highest approved dose
•\-Ability to understand and follow study\-related instructions
•\-At least 4 attempts at sexual intercourse on 4 separate days during the open\-label run\-in phase with use of 20 mg vardenafil approximately 1 hour before attempting intercourse (according to the answer to the following question in the Subject Diary: Was sexual activity initiated with the intention of intercourse?)
•\-IIEF EF score \<17
•\-At least 50% of attempts at sexual intercourse during the open\-label run\-in phase were unsuccessful, i.e. the following question in the Subject Diary will have to be answered with No:

•\-Incompletely cured pre\-existing diseases that may influence absorption, distribution, metabolism, elimination, or effects of the study drugs
•\-Known hypersensitivity to the study drugs (active substances or excipients of the formulations)
•\-Known severe allergies, non\-allergic drug reactions, or multiple drug allergies
•\-Any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity
•\-History of myocardial infarction, stroke, or life\-threatening arrhythmia within 6 months prior to screening
•\-Bleeding disorder
•\-History of prostatectomy due to prostate cancer, including nerve\-sparing techniques. Clarification: Any surgical procedures for the treatment of benign prostatic hypertrophy (BPH) are permitted, with the exception of cryosurgery, cryotherapy, and cryoablation
•\-Hereditary degenerative retinal disorders such as retinitis pigmentosa
•\-History of loss of vision due to non\-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision, including unilateral loss of vision
•\-History of uni\- or bilateral hearing loss

Not specified