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).

Bayer0 sites37 target enrollmentJanuary 2010

ConditionsErectile Dysfunction

InterventionsBAY60-4552 + Vardenafil Placebo

DrugsBAY60-4552 + Vardenafil Placebo

Overview

Phase: Phase 1
Intervention: BAY60-4552 + Vardenafil
Conditions: Erectile Dysfunction
Sponsor: Bayer
Enrollment: 37
Primary Endpoint: Adverse Event reporting
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

May 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Bayer

Eligibility Criteria

Inclusion Criteria

•The informed consent must be signed before any study specific tests or procedures are done
•Male patients with a history of erectile dysfunction (ED) for at least 6 months, defined as "the inability to achieve and maintain an erection of the penis sufficient to complete satisfactory sexual intercourse" by the NIH consensus report
•The diagnosis of 'Erectile dysfunction' has to be confirmed by a physician
•Age: 18 to 70 years (inclusive) at the first screening examination
•Ethnicity: White
•Body mass index (BMI): equal to or above 18 and below 32 kg / m²
•Confirmation of the patient's health insurance coverage prior to the first screening examination / visit
•Ability to understand and follow study-related instructions

Exclusion Criteria

•Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
•Known hypersensitivity to the study drugs (active substances or excipients of the preparations)
•Known severe allergies, non-allergic drug reactions, or multiple drug allergies
•Any underlying cardiovascular condition, including unstable angina pectoris that would preclude sexual activity according to the NIH consensus report 1993
•History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to screening
•Bleeding disorder
•History of prostatectomy because of prostate cancer, including nerve-sparing techniques. Clarification: Any surgical procedures for the treatment of Benign Prostate Hypertrophy (BPH) are permitted, with the exception of cryosurgery, cryotherapy or cryoablation
•Hereditary degenerative retinal disorders such as retinitis pigmentosa
•History of loss of vision because of NAION (Bayer Study 12912), temporary or permanent loss of vision, including unilateral loss of vision
•History of uni- or bilateral hearing loss

Arms & Interventions

Arm 1

Intervention: BAY60-4552 + Vardenafil

Arm 2

Intervention: BAY60-4552 + Vardenafil

Arm 3

Intervention: BAY60-4552 + Vardenafil

Arm 4

Intervention: Placebo

Outcomes

Primary Outcomes

Adverse Event reporting

Time Frame: up to 6 weeks

Secondary Outcomes

Plasma concentration of study drugs; Pharmacokinetic parameters: AUC, Cmax, AUC/D, Cmax;norm, Cmax/D, t1/2, tmax(Day 0, 6, 13)
Plasma concentration of cyclic guanosine monophosphate (cGMP)(Day 0, 6, 13)