Status:
COMPLETED
BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction
Lead Sponsor:
Bayer
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18-64 years
Phase:
PHASE4
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 th...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00665054
Start Date
August 1 2004
End Date
August 1 2005
Last Update
December 25 2014
Active Locations (8)
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1
Adana, Turkey (Türkiye), 01330
2
Ankara, Turkey (Türkiye), 06100
3
Ankara, Turkey (Türkiye), 06500
4
Antalya, Turkey (Türkiye), 07003