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BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction

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: NCT00665054
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : December 25, 2014
Information provided by (Responsible Party):

Brief Summary:
Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo- To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multi-centre, Randomized, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy and Tolerability of Vardenafil and Its Influence on Self-esteem and Self Confidence in Subjects With Erectile Dysfunction.
Study Start Date : August 2004
Actual Primary Completion Date : August 2005
Actual Study Completion Date : August 2005

Arm Intervention/treatment
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity

Placebo Comparator: Arm 2 Drug: Placebo
Matching placebo tablets orally prior to sexual activity

Primary Outcome Measures :
  1. LOCF improved compared to baseline GAQ results at the end of the study [ Time Frame: baseline versus visit 2 visit 5 or premature termination visit ]

Secondary Outcome Measures :
  1. IIEF scores [ Time Frame: visits 3, 4 and 5 ]
  2. OF, SD, IS scores in IIEF Questionnaire [ Time Frame: visits 2, 3, 4, 5 or at premature termination visit ]
  3. Scores of all individual questions on IIEF questionnaire [ Time Frame: visits 2, 3, 4, 5 or at premature termination visit ]
  4. Subject's diary response [ Time Frame: baseline and after randomization per visit period ]
  5. SSES-E scores [ Time Frame: visits 2 and 5 or premature termination visit ]
  6. Summary score from the responses to SSES-E [ Time Frame: visits 2 and 5 or premature termination visit ]
  7. Response scores and summary score from the responses to the SF-36 [ Time Frame: visits 2 and 5 or premature termination visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men with heterosexual relationships aged 18 - 64 years suffering from ED for more than 6 months according to the NIH Consensus Statement (i.e. inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
  • At least 4 attempts at sexual intercourse (according to the question in the subject diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary.

Exclusion Criteria:

  • Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease) that in the investigator's opinion would significantly impair sexual performance.
  • Primary hypoactive sexual desire.-Spinal cord injury-History of surgical prostatectomy (transurethral interventions not excluded).
  • Unstable angina pectoris.
  • History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
  • Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate >100 BPM).

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): NCT00665054

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Adana, Turkey, 01330
Ankara, Turkey, 06100
Ankara, Turkey, 06500
Antalya, Turkey, 07003
Istanbul, Turkey, 34098
Istanbul, Turkey, 34662
Izmir, Turkey, 35340
Samsun, Turkey, 55139
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
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Responsible Party: Bayer Identifier: NCT00665054    
Other Study ID Numbers: 11382
First Posted: April 23, 2008    Key Record Dates
Last Update Posted: December 25, 2014
Last Verified: December 2014
Keywords provided by Bayer:
Erectile dysfunction
SSES-E (sexual self-efficacy scale - erectile function)
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