Erectile Dysfunction Clinical Trial
Official title:
A Prospective, Randomized, Double-blind, Double-dummy, Placebo- and Active Controlled, Multicenter Study Assessing the Efficacy and Safety of the Combination BAY60-4552 / Vardenafil Compared to Vardenafil (20 mg) for the Treatment of Erectile Dysfunction Not Sufficiently Responsive to Standard Therapy With PDE5 (Phosphodiesterase 5) Inhibitors
This study examines the efficacy and safety of the combination treatment BAY60-4552 plus
vardenafil in patients with erectile dysfunction, who do not sufficiently respond to therapy
with PDE5 (Phosphodiesterase 5) inhibitors.
Patients meeting the entry criteria, will receive vardenafil alone in the first four weeks
of the study to assess the effect of PDE5 inhibitor therapy given alone.
Patients with an insufficient therapeutic response to vardenafil alone will enter the next
part of the study, and will be randomly assigned to one of 3 treatments. There is a 1 in 3
chance of receiving either the combination BAY60-4552 plus vardenafil, or vardenafil alone,
or placebo. Neither patient nor the treating physician will know which treatment is given
(double-blinded design).This part of the study will last four weeks Patients will have to go
to the clinic/hospital for 7 visits during the 8 weeks.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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