check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

100540

ClinicalTrials.gov Identifier:

NCT00660998

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of efficacy and safety of Vardenafil in patients with erectile dysfunction and type 1 diabetes

Trial purpose

Asses efficacy of Vardenafil in patients with type 1 diabetes and erectile dysfunction

Key Participants Requirements

Sex

Male

Age

18 Years
  • - 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.
  • - Primary hypoactive sexual desire
    - History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
    - Nitrate therapy

Trial summary

Enrollment Goal
318
Trial Dates
February 2003 - January 2004
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Germany

Primary Outcome

  • Sexual Encounter Profile Question 2
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Sexual Encounter Profile Question 3
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • International Index of Erectile Function - Erectile Function Domain
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Safety and Tolerability
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    yes

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.