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BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

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ClinicalTrials.gov Identifier: NCT00668057
Recruitment Status : Completed
First Posted : April 28, 2008
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 624 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Multi-centre, Parallel-goup Study to Investigate the Efficacy and Safety of Three Doses of BAY38-9456 (5 mg, 10 mg and 20 mg) Versus Placebo in the Treatment of Patients With Erectile Dysfunction
Study Start Date : December 2002
Actual Primary Completion Date : September 2003
Actual Study Completion Date : September 2003


Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
5 mg Vardenafil orally 1 hour prior to sexual intercourse
Experimental: Arm 2 Drug: Levitra (Vardenafil, BAY38-9456)
10 mg Vardenafil orally 1 hour prior to sexual intercourse
Experimental: Arm 3 Drug: Levitra (Vardenafil, BAY38-9456)
20 mg Vardenafil orally 1 hour prior to sexual intercourse
Placebo Comparator: Arm 4 Drug: Placebo
5 mg matching placebo
Placebo Comparator: Arm 5 Drug: Placebo
10 mg matching placebo
Placebo Comparator: Arm 6 Drug: Placebo
20 mg matching placebo



Primary Outcome Measures :
  1. Erectile Function domain score of the International Index of Erectile Function, questions 1-5 and 15 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Global Assessment Questionnaire [ Time Frame: 12 weeks ]
  2. Erectile Function domain score of the International Index of Erectile Function [ Time Frame: 12 weeks ]
  3. Safety and tolerability [ Time Frame: 12 weeks ]


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Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men with ED for more than 6 months. ED defined according to the National Institute of Health, USA Department of Health and Human Services, consensus statement, as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance.
  • Stable heterosexual relationship

Exclusion Criteria:

  • Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the 6-month period prior to Visit 1 (Week -4)
  • Nitrate use
  • Other exclusion criteria apply

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 ClinicalTrials.gov identifier (NCT number): NCT00668057


Locations
China, Zhejiang
Hangzhou, Zhejiang, China, 310003
China
Beijing, China, 100034
Beijing, China, 100044
Beijing, China, 100083
Beijing, China, 100853
Shanghai, China, 200040
Shanghai, China, 200127
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00668057     History of Changes
Other Study ID Numbers: 10690
First Posted: April 28, 2008    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Bayer:
Male Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Vardenafil Dihydrochloride
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents