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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00668096
• Date of registration: 24/04/2008
• Prospective Registration: No
• Primary sponsor: Bayer
• Public title: A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy. FINDER
• Scientific 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.
• Date of first enrolment: May 2004
• Target sample size: 260
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00668096
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

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

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Erectile Dysfunction

Intervention(s)

Drug: Placebo

Drug: Levitra (Vardenafil, BAY38-9456)

Primary Outcome(s)

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 Outcome(s)

Safety and tolerability [Time Frame: 16 weeks]

Treatment Satisfaction Scale [Time Frame: 16 weeks]

Other patient diary based variables [Time Frame: 16 weeks]

International Index of Erectile Function [Time Frame: 16 weeks]

Secondary ID(s)

11334

Source(s) of Monetary Support

Please refer to primary and secondary sponsors