Assessment of Efficacy of Vardenafil, Influence on Self-Esteem and Self-Confidence in Subjects With Erectile Dysfunction
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
Assessment of efficacy of vardenafil, influence on self-esteem and self-confidence in
subjects with erectile dysfunction
Clinical Details
Official title: Multi-Centre, Randomized, Double-Blind, Parallel, Placebo-Controlled Clinical Study to Assess the Efficacy of Vardenafil and Its Influence on Self-Esteem and Self-Confidence in Patients With Erectile Dysfunction
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: International Index of Erectile Function - Erectile Function Domain
Secondary outcome: Global Assessment QuestionnaireIIEF-EF domain score Other diary based variables Safety and tolerability
Detailed description:
Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress.
The purpose of this national study was to determine if vardenafil is effective in treating
impotent men (erectile dysfunction) and evaluate its influence in self-esteem and
self-confidence. During the visits the patients was asked some questions about erections, and
he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual
activity.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Age: 18 years and older
- Males with erectile dysfunction
- Stable heterosexual relationship
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 acc. to Summary of Product Characteristics
Locations and Contacts
Alicante 03010, Spain
Granada 18003, Spain
Málaga 29010, Spain
Sevilla 41071, Spain
Valencia 46014, Spain
Valladolid 47011, Spain
Oviedo, Asturias 33006, Spain
Sabadell, Barcelona 08208, Spain
Barcelona, Cataluña 08025, Spain
Hondarribia, Guipuzcoa 28280, Spain
Móstoles, Madrid 28935, Spain
Vigo, Pontevedra 36211, Spain
Additional Information
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Starting date: May 2003
Ending date: January 2004
Last updated: April 17, 2008
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