Trial Condition(s):
Erectile Dysfunction
Evaluation of efficacy and safety of Vardenafil in patients with erectile dysfunction and type 1 diabetes
Bayer Identifier:
100540
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Sexual Encounter Profile Question 2Timeframe: 12 weeks
- Sexual Encounter Profile Question 3Timeframe: 12 weeks
Secondary Outcome
- International Index of Erectile Function - Erectile Function DomainTimeframe: 12 weeks
- Safety and TolerabilityTimeframe: 12 weeks
Additional Information
Copyright © Bayer
Powered by
