Multiple Dose Escalation Study (14 Days) to Investigate Safety, Tolerability, PK and PD of Vardenafil and BAY60-4552

Bayer

Status and phase

Completed

Phase 1

Conditions

Erectile Dysfunction

Treatments

Drug: Placebo

Drug: BAY60-4552 + Vardenafil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01110590

14612

2009-015894-11 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

37 patients

Sex

Male

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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 1993. 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