BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction
Multi-centre, Randomized, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy and Tolerability of Vardenafil and Its Influence on Self-esteem and Self Confidence in Subjects With Erectile Dysfunction.
1 other identifier
interventional
160
1 country
8
Brief Summary
Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo- To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Aug 2004
Shorter than P25 for phase_4
8 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
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 18, 2008
CompletedFirst Posted
Study publicly available on registry
April 23, 2008
CompletedDecember 25, 2014
December 1, 2014
1 year
April 18, 2008
December 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
LOCF improved compared to baseline GAQ results at the end of the study
baseline versus visit 2 visit 5 or premature termination visit
Secondary Outcomes (7)
IIEF scores
visits 3, 4 and 5
OF, SD, IS scores in IIEF Questionnaire
visits 2, 3, 4, 5 or at premature termination visit
Scores of all individual questions on IIEF questionnaire
visits 2, 3, 4, 5 or at premature termination visit
Subject's diary response
baseline and after randomization per visit period
SSES-E scores
visits 2 and 5 or premature termination visit
- +2 more secondary outcomes
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
5, 10, or 20 mg Vardenafil tablets orally prior to sexual activity
Eligibility Criteria
You may qualify if:
- Men with heterosexual relationships aged 18 - 64 years suffering from ED for more than 6 months according to the NIH Consensus Statement (i.e. inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
- At least 4 attempts at sexual intercourse (according to the question in the subject diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary.
You may not qualify if:
- Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease) that in the investigator's opinion would significantly impair sexual performance.
- Primary hypoactive sexual desire.-Spinal cord injury-History of surgical prostatectomy (transurethral interventions not excluded).
- Unstable angina pectoris.
- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
- Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate \>100 BPM).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- GlaxoSmithKlinecollaborator
Study Sites (8)
Unknown Facility
Adana, 01330, Turkey (Türkiye)
Unknown Facility
Ankara, 06100, Turkey (Türkiye)
Unknown Facility
Ankara, 06500, Turkey (Türkiye)
Unknown Facility
Antalya, 07003, Turkey (Türkiye)
Unknown Facility
Istanbul, 34098, Turkey (Türkiye)
Unknown Facility
Istanbul, 34662, Turkey (Türkiye)
Unknown Facility
Izmir, 35340, Turkey (Türkiye)
Unknown Facility
Samsun, 55139, Turkey (Türkiye)
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 4
- 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 18, 2008
First Posted
April 23, 2008
Study Start
August 1, 2004
Primary Completion
August 1, 2005
Study Completion
August 1, 2005
Last Updated
December 25, 2014
Record last verified: 2014-12