Skip to main content
OpenTrials
Completed

NCT Number: NCT00665496

A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction

This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.

Completed

Looking for future studies?

Notify Me

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 and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males with ED for more than 6 months according to the NIH Consensus statement(inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
  • Heterosexual relationship
  • 18 years and older

Exclusion criteria

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life threatening arrhythmia within the prior 6 months
  • Nitrates or nitric oxide donors use
  • Other exclusion criteria according to the US Product Information

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

Vardenafil 10 mg and 20 mg orally once a day as needed

Placebo

Drug

Matching Placebo

Primary outcomes

  1. - Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3)

    Time frame: First four doses with successful intercourse

Secondary outcomes

  1. - Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration as measured by Sexual Encounter Profile Question 2 (SEP 2).

    Time frame: among the first four doses

  2. - The erectile function (EF) domain score of the International Index of Erectile Function (IIEF) calculated as the sum of scores from Questions 1-5 and 15 at Week 4 as well as all other IIEF factor subscores.

    Time frame: among the first four doses

  3. - Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration.

    Time frame: among the first four doses

  4. - Other diary questions

    Time frame: among the first four doses

  5. - Safety and tolerability

    Time frame: within the study duration

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Randomized, Double Blind, Double Dummy, Parallel Group, Multi-center Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction.

Important dates

Study start
2003
Study completion
2003
First posted
Apr 24, 2008
Registry last updated
Dec 17, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.