Status:
COMPLETED
To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.
Lead Sponsor:
Bayer
Conditions:
Erectile Dysfunction
Eligibility:
MALE
21+ years
Phase:
PHASE3
Brief Summary
To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.
Eligibility Criteria
Inclusion
- Men 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months
- having at least a 50% failure rate of sexual intercourse attempts during the run-in phase
Exclusion
- Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded.
- Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded.
- Subjects could not be on androgens/anti-androgens or alpha blockers.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT00661115
Start Date
May 1 2003
End Date
February 1 2004
Last Update
December 16 2014
Active Locations (6)
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1
Bangalore, Karnataka, India, 560010
2
Bangalore, Karnataka, India, 560054
3
Belagum, Karnataka, India, 590010
4
Mumbai, Maharashtra, India, 400007