A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy. (FINDER)
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ClinicalTrials.gov Identifier: NCT00668096 |
Recruitment Status :
Completed
First Posted : April 28, 2008
Last Update Posted : December 25, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Erectile Dysfunction | Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo | Phase 4 |
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 |

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 |
- 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 ]
- International Index of Erectile Function [ Time Frame: 16 weeks ]
- Treatment Satisfaction Scale [ Time Frame: 16 weeks ]
- Other patient diary based variables [ Time Frame: 16 weeks ]
- Safety and tolerability [ Time Frame: 16 weeks ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668096
Belgium | |
Bruxelles - Brussel, Belgium, 1000 | |
Drieslinter, Belgium, 3350 | |
Genk, Belgium, 3600 | |
Leuven, Belgium, 3000 | |
Denmark | |
Gentofte, Denmark, DK-2820 | |
Naestved, Denmark, 4700 | |
Svendborg, Denmark, DK-5700 | |
Viborg, Denmark, 8800 | |
Finland | |
Kerava, Finland, 04250 | |
Oulu, Finland, 90100 | |
Tampere, Finland, 33100 | |
France | |
Grenoble, France, 38000 | |
Lille, France, 59000 | |
Lyon, France, 69000 | |
Marseille, France, 13009 | |
Marseille, France, 13013 | |
Marseille, France, 13015 | |
Montpellier, France, 34000 | |
Germany | |
Dresden, Sachsen, Germany, 01129 | |
Leipzig, Sachsen, Germany, 04105 | |
Leipzig, Sachsen, Germany, 04249 | |
Leisnig, Sachsen, Germany, 04703 | |
Meißen, Sachsen, Germany, 01662 | |
Harrislee, Schleswig-Holstein, Germany, 24955 | |
Norderstedt, Schleswig-Holstein, Germany, 22846 | |
Wahlstedt, Schleswig-Holstein, Germany, 23812 | |
Altenburg, Thüringen, Germany, 04600 | |
Hamburg, Germany, 22177 | |
Hamburg, Germany, 22299 | |
Hamburg, Germany, 22303 | |
Spain | |
Gavà, Barcelona, Spain, 08850 | |
L'Hospitalet de Llobregat, Barcelona, Spain, 08905 | |
Badalona (Barcelona), Cataluña, Spain, 08043 | |
Barcelona, Spain, 08032 | |
United Kingdom | |
Crowborough, East Sussex, United Kingdom, TN6 1DL | |
Chipping Norton, Oxfordshire, United Kingdom, OX7 5AL | |
Lichfield, Staffordshire, United Kingdom, WS14 9JL | |
Hamilton, Strathclyde, United Kingdom, ML3 ODR |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT00668096 |
Other Study ID Numbers: |
11334 |
First Posted: | April 28, 2008 Key Record Dates |
Last Update Posted: | December 25, 2014 |
Last Verified: | December 2014 |
Erectile Dysfunction PDE5 inhibitors |
Erectile Dysfunction Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Mental Disorders Vardenafil Dihydrochloride Vasodilator Agents |
Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Urological Agents |