Evaluation of Efficacy and Safety of Vardenafil in Patients With Erectile Dysfunction and Type 1 Diabetes
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction
Clinical Details
Official title: A Rand, db, Parallel-Group, Plac-Controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-Dose Regimen Compared to Plac in Men With Diabetes Mellitus Type 1 and Erectile Dysfunction
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Sexual Encounter Profile Question 2Sexual Encounter Profile Question 3
Secondary outcome: International Index of Erectile Function - Erectile Function DomainSafety and Tolerability
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Men ≥ 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH
Consensus statement,
- Diabetes type 1
- Stable sexual relationship for > 6 month.
Exclusion Criteria:
- Primary hypoactive sexual desire
- History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6
month
- Nitrate therapy
Locations and Contacts
Additional Information
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Starting date: February 2003
Ending date: January 2004
Last updated: April 17, 2008
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