Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552 and vardenafil will be given with patients with erectile dysfunction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
37
Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil
Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil
Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil
Unnamed facility
Mönchengladbach, North Rhine-Westphalia, Germany
Adverse Event reporting
Time frame: up to 6 weeks
Plasma concentration of study drugs; Pharmacokinetic parameters: AUC, Cmax, AUC/D, Cmax;norm, Cmax/D, t1/2, tmax
Time frame: Day 0, 6, 13
Plasma concentration of cyclic guanosine monophosphate (cGMP)
Time frame: Day 0, 6, 13
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Placebo