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Completed

NCT Number: NCT00665340

Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)

This study was conducted to evaluate in adult men with erectile dysfunction (often called impotence), the effect of vardenafil HCl on the quality of their erections. Many men experience occasional erectile problems during their lives. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl. In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like the real drug but it is not. It contains no active ingredients.

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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

Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

- Males who have had ED for at least six months- Heterosexual relationship.- Males 18 and older. Exclusion Criteria:- Primary hypoactive sexual desire.- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.- Stable heterosexual relationship for > 6 month- Other exclusion criteria apply according to the US Product Information

Treatment and study plan

Placebo

Drug

Matching placebo

Levitra (Vardenafil, BAY38-9456)

Drug

5m, 10 mg and 20 mg 1 h prior to sexual intercourse

Primary outcomes

  1. Erection Quality Scale

    Time frame: Week 8

Secondary outcomes

  1. Erection Quality Scale

    Time frame: Week 4 and 8

  2. International Index of Erectile Function- Erectile Function domain score

    Time frame: Week 4 and 8

  3. Per-subject success rates based on Sexual Encounter Profile, Question 2

    Time frame: Week 4, 8 Week 8

  4. Safety and tolerability

    Time frame: Week 8

  5. Patient Diary Questions

    Time frame: Weeks 4, 8 Week 8

  6. Global Assessment Question (GAQ)

    Time frame: Weeks 4, 8 of treatment and Week 8

  7. Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25)

    Time frame: Week 8-LOCF

  8. Penetration (SEP2) and Maintenance (SEP3) reliability

    Time frame: Week 8-LOCF

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo-controlled, Parallel Group, Multi-center Study to Investigate the Responsiveness of the Erectile Quality Scale (EQS) to Vardenafil HCl Flexible Dose Versus Placebo in Males With Erectile Dysfunction.

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Apr 23, 2008
Registry last updated
Oct 11, 2013

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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