Randomized, Double-blind, Placebo-controlled, Group-comparison, Dose-escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Co-administration of Different Doses of Vardenafil (2 Dose Strengths) and BAY60-4552 (4 Dose Strengths) Given Once-daily (od) Over 14 Days in Patients With Erectile Dysfunction (ED).

NCT01110590 Phase 1 COMPLETED

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.

Details

Lead sponsor	Bayer
Phase	Phase 1
Status	COMPLETED
Enrolment	37
Start date	2010-01
Completion	2010-05

Conditions

• Erectile Dysfunction

Interventions

• BAY60-4552 + Vardenafil
• BAY60-4552 + Vardenafil
• BAY60-4552 + Vardenafil
• Placebo

Primary outcomes

• Adverse Event reporting — up to 6 weeks

Countries

Germany