Trial Condition(s):
Erectile Dysfunction
Assessment of efficacy of vardenafil, influence on self-esteem and self-confidence in subjects with erectile dysfunction
Bayer Identifier:
11139
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Málaga, Spain, 29010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valladolid, Spain, 47011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Móstoles, Spain, 28935 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Alicante, Spain, 03010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Oviedo, Spain, 33006 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sevilla, Spain, 41071 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Valencia, Spain, 46014 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sabadell, Spain, 08208 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vigo, Spain, 36211 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hondarribia, Spain, 28280 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Granada, Spain, 18003 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- International Index of Erectile Function - Erectile Function DomainTimeframe: 12 weeks
Secondary Outcome
- Global Assessment QuestionnaireTimeframe: 12 weeks
- IIEF-EF domain scoreTimeframe: 12 weeks
- Other diary based variablesTimeframe: 12 weeks
- Safety and tolerabilityTimeframe: 12 weeks
Additional Information
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