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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00668096

Acronym

FINDER

Enrollment

260

Registered

2008-04-28

Start date

2004-05-31

Completion date

2005-01-31

Last updated

2014-12-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction, PDE5 inhibitors

Brief summary

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.

Interventions

DRUGLevitra (Vardenafil, BAY38-9456)

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

DRUGPlacebo

Matching Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 64 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	16 weeks

Secondary

Measure	Time frame
International Index of Erectile Function	16 weeks
Treatment Satisfaction Scale	16 weeks
Other patient diary based variables	16 weeks
Safety and tolerability	16 weeks

Countries

Belgium, Denmark, Finland, France, Germany, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026