Skip to main content
OpenTrials
Completed

NCT Number: NCT00663598

Levitra® - Real Life Safety and Efficacy of Levitra

Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)

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 4

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male outpatients >/= 18 years of age with a diagnosis of ED according to the 1992 US National Institutes of Health (NIH) Consensus Statement (the inability to achieve and maintain penile erection sufficient to complete satisfactory intercourse), and independent of any previous ED treatment

Exclusion criteria

  • Exclusion according to US PI

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

Treatment according to US PI

Primary outcomes

  1. Improvement of Erectile Disfunction

    Time frame: 8 weeks

  2. Onset of Drug Effect

    Time frame: 8 weeks

  3. Second successful intercourse

    Time frame: 8 weeks

Secondary outcomes

  1. General Safety Parameters

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

REALISE Levitra® - Real Life Safety and Efficacy of Levitra

Acronym: REALISE

Important dates

Study start
2003
Study completion
2004
First posted
Apr 22, 2008
Registry last updated
Dec 19, 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.