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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01110590
Recruitment Status : Completed
First Posted : April 26, 2010
Last Update Posted : February 22, 2013
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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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: BAY60-4552 + Vardenafil Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: 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).
Study Start Date : January 2010
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Vardenafil

Arm Intervention/treatment
Experimental: Arm 1 Drug: BAY60-4552 + Vardenafil
Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil

Experimental: Arm 2 Drug: BAY60-4552 + Vardenafil
Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil

Experimental: Arm 3 Drug: BAY60-4552 + Vardenafil
Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil

Placebo Comparator: Arm 4 Drug: Placebo

Primary Outcome Measures :
  1. Adverse Event reporting [ Time Frame: up to 6 weeks ]

Secondary Outcome Measures :
  1. Plasma concentration of study drugs; Pharmacokinetic parameters: AUC, Cmax, AUC/D, Cmax;norm, Cmax/D, t1/2, tmax [ Time Frame: Day 0, 6, 13 ]
  2. Plasma concentration of cyclic guanosine monophosphate (cGMP) [ Time Frame: Day 0, 6, 13 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01110590

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Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Head Clinical Pharmacology, Bayer HealthCare AG Identifier: NCT01110590    
Other Study ID Numbers: 14612
2009-015894-11 ( EudraCT Number )
First Posted: April 26, 2010    Key Record Dates
Last Update Posted: February 22, 2013
Last Verified: February 2013
Keywords provided by Bayer:
Erectile Dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents