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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Erectile Dysfunction	Drug: Levitra (Vardenafil, BAY38-9456); Drug: Placebo	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	260 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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.
Study Start Date :	May 2004
Actual Primary Completion Date :	January 2005
Actual Study Completion Date :	January 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Placebo Comparator: Arm 2	Drug: Placebo; Matching Placebo
Experimental: Arm 1	Drug: Levitra (Vardenafil, BAY38-9456); Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 64 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 38 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:	Bayer Study Director	Bayer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT00668096 History of Changes
Other Study ID Numbers:	11334
First Posted:	April 28, 2008
Last Update Posted:	December 25, 2014
Last Verified:	December 2014

Keywords provided by Bayer:

Erectile Dysfunction; PDE5 inhibitors

Additional relevant MeSH terms:

Erectile Dysfunction; Sexual Dysfunction, Physiological; Genital Diseases, Male; Sexual Dysfunctions, Psychological; Mental Disorders; Vardenafil Dihydrochloride	Phosphodiesterase 5 Inhibitors; Vasodilator Agents; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Urological Agents