Study Completed

Erectile Dysfunction

Bayer Identifier:

14612

ClinicalTrials.gov Identifier:

NCT01110590

EudraCT Number:

2009-015894-11

EU CT Number:

Not Available

Multiple dose escalation study (14 days) to investigate safety, tolerability, PK and PD of vardenafil and BAY60-4552

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - 70 Years

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

Trial summary

Enrollment Goal

Trial Dates

January 2010 - May 2010

Phase

Phase 1

Could I Receive a placebo

Yes

Products

BAY98-7081

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	CRS Clinical-Research-Services Mönchengladbach GmbH	Mönchengladbach, 41061, Germany

Primary Outcome

Adverse Event reporting
Time Frame:
up to 6 weeks
Safety Issue:
yes

Secondary Outcome

Plasma concentration of study drugs; Pharmacokinetic parameters: AUC, Cmax, AUC/D, Cmax;norm, Cmax/D, t1/2, tmax
Time Frame:
Day 0, 6, 13
Safety Issue:
No
Plasma concentration of cyclic guanosine monophosphate (cGMP)
Time Frame:
Day 0, 6, 13
Safety Issue:
no

Trial design

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).

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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