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A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy. (FINDER)
This study has been completed.
Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00668096
First received: April 24, 2008
Last updated: December 23, 2014
Last verified: December 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Erectile Dysfunction | Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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. |
Resource links provided by NLM:
MedlinePlus related topics:
Erectile Dysfunction
Drug Information available for:
Vardenafil
Vardenafil hydrochloride
Vardenafil dihydrochloride
Vardenafil hydrochloride trihydrate
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- 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:
- 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 ]
| Enrollment: | 260 |
| Study Start Date: | May 2004 |
| Study Completion Date: | January 2005 |
| Primary Completion Date: | January 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668096
Show 38 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668096
Show 38 Study Locations
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00668096 History of Changes |
| Other Study ID Numbers: |
11334 |
| Study First Received: | April 24, 2008 |
| Last Updated: | December 23, 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 Phosphodiesterase 5 Inhibitors |
Vardenafil Dihydrochloride Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vasodilator Agents Urological Agents |
ClinicalTrials.gov processed this record on June 23, 2017