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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 Questionnaire

IIEF-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

Page last updated: August 23, 2015

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