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Completed

NCT Number: NCT00668096

A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.

The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with 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

Bruxelles - Brussel, Belgium

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 erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance
  • Heterosexual relationship for more than 6 months
  • Partner willing to complete the TSS

Exclusion criteria

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
  • Nitrate use
  • Other exclusion criteria apply according to the Summary of Product Characteristics

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity

Placebo

Drug

Matching Placebo

Primary outcomes

  1. Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign.

    Time frame: 16 weeks

Secondary outcomes

  1. International Index of Erectile Function

    Time frame: 16 weeks

  2. Treatment Satisfaction Scale

    Time frame: 16 weeks

  3. Other patient diary based variables

    Time frame: 16 weeks

  4. Safety and tolerability

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled, Flexible Dose, Multicentre Study of Levitra in a Broad Population of Men With Erectile Dysfunction and Previously Untreated With PDE5 Inhibitors.

Acronym: FINDER

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Apr 28, 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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