Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction
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
1 other identifier
interventional
129
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2003
Shorter than P25 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 15, 2008
CompletedFirst Posted
Study publicly available on registry
April 18, 2008
CompletedDecember 30, 2014
December 1, 2014
8 months
April 15, 2008
December 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
International Index of Erectile Function - Erectile Function Domain
12 weeks
Secondary Outcomes (4)
Global Assessment Questionnaire
12 weeks
IIEF-EF domain score
12 weeks
Other diary based variables
12 weeks
Safety and tolerability
12 weeks
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Age: 18 years and older
- Males with erectile dysfunction
- Stable heterosexual relationship
You may not qualify if:
- Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
- Nitrate use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (13)
Unknown Facility
Alicante, Alicante, 03010, Spain
Unknown Facility
Sabadell, Barcelona, 08208, Spain
Unknown Facility
Barcelona, Catalonia, 08025, Spain
Unknown Facility
Granada, Granada, 18003, Spain
Unknown Facility
Hondarribia, Guipuzcoa, 28280, Spain
Unknown Facility
Leganés, Madrid, 28911, Spain
Unknown Facility
Móstoles, Madrid, 28935, Spain
Unknown Facility
Málaga, Málaga, 29010, Spain
Unknown Facility
Vigo, Pontevedra, 36211, Spain
Unknown Facility
Oviedo, Principality of Asturias, 33006, Spain
Unknown Facility
Seville, Sevilla, 41071, Spain
Unknown Facility
Valencia, Valencia, 46014, Spain
Unknown Facility
Valladolid, Valladolid, 47011, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2008
First Posted
April 18, 2008
Study Start
May 1, 2003
Primary Completion
January 1, 2004
Study Completion
January 1, 2004
Last Updated
December 30, 2014
Record last verified: 2014-12