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

Erectile Dysfunction Clinical Trial

— FINDER  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668096
• Other study ID #: 11334
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2008
• Last updated: December 23, 2014
• Start date: May 2004
• Est. completion date: January 2005

Study information

• Verified date: December 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: National Health ServiceBelgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Medicines AgencyFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity
• Placebo
Matching Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	International Index of Erectile Function		16 weeks	No
Secondary	Treatment Satisfaction Scale		16 weeks	No
Secondary	Other patient diary based variables		16 weeks	No
Secondary	Safety and tolerability		16 weeks	Yes

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find results for studies related to Bayer Healthcare products.