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

Bayer HealthCare AG0 个研究点目标入组 267 人开始时间: 2010年8月31日最近更新: 2013年5月6日

试验速览

暂无简介。

•Open-label run-in phase (first four weeks)
•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; 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
•History of previous use of at least 1 marketed PDE5 inhibitor and insufficient therapeutic efficacy despite use of the highest approved dose
•Double-blind treatment phase (last four weeks)
•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
•IIEF EF score <17
•At least 50% of attempts at sexual intercourse during the open-label run-in phase were unsuccessful
•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) no
•F.1.3.1 Number of subjects for this age range

•Contraindication to use of vardenafil
•History of prostatectomy due to prostate cancer, including nerve-sparing techniques.
•Concomitant use of adrenergic blockers
•History of spinal cord injury
•Resting hypotension, i.e. SBP <100 mmHg at rest
•Moderate / severe hypertension, i.e. SBP >170 mmHg or DBP >110 mmHg at rest
•Symptomatic orthostatic hypotension with a decrease in SBP >20 mmHg or in DBP >10 mmHg subsequent to change from the supine to standing position
•History of pelvic radiotherapy
•Pulmonary venous occlusive disease

发起方