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Completed

NCT Number: NCT00665054

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

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

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Adana, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity

Placebo

Drug

Matching placebo tablets orally prior to sexual activity

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • GlaxoSmithKline

Registry information

Official study 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.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Apr 23, 2008
Registry last updated
Dec 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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