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

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).

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 Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Placebo; Drug: BAY60-4552 + Vardenafil; Drug: BAY60-4552 + Vardenafil; Drug: BAY60-4552 + Vardenafil

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Nordrhein-Westfalen
    • Mönchengladbach, Nordrhein-Westfalen, Germany, 41061

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: BAY60-4552 + Vardenafil; Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil; Drug: BAY60-4552 + Vardenafil; Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil; Drug: BAY60-4552 + Vardenafil; Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil
Experimental: Arm 2	Drug: BAY60-4552 + Vardenafil; Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil; Drug: BAY60-4552 + Vardenafil; Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil; Drug: BAY60-4552 + Vardenafil; Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil
Experimental: Arm 3	Drug: BAY60-4552 + Vardenafil; Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil; Drug: BAY60-4552 + Vardenafil; Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil; Drug: BAY60-4552 + Vardenafil; Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil
Placebo Comparator: Arm 4	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Event reporting	up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: April 14, 2010
• First Submitted That Met QC Criteria: April 23, 2010
• First Posted (Estimate): April 26, 2010

Study Record Updates

• Last Update Posted (Estimate): February 22, 2013
• Last Update Submitted That Met QC Criteria: February 21, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Erectile Dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Vardenafil Dihydrochloride
• Other Study ID Numbers: 14612; 2009-015894-11 (EudraCT Number)