Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 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
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.
Clinical Details
Official title: Multi-centre, Randomised, 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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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
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
Leganés, Madrid 28911, Spain
Móstoles, Madrid 28935, Spain
Vigo, Pontevedra 36211, Spain
Additional Information
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Starting date: May 2003
Last updated: December 28, 2014
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