check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

100477

ClinicalTrials.gov Identifier:

NCT00663598

EudraCT Number:

Not Available

EU CT Number:

Not Available
Levitra® - Real Life Safety and Efficacy of Levitra

Trial purpose

Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)

Key Participants Requirements

Sex

Male

Age

18 Years
  • - Male outpatients >/= 18 years of age with a diagnosis of ED according to the 1992 US National Institutes of Health (NIH) Consensus Statement (the inability to achieve and maintain penile erection sufficient to complete satisfactory intercourse), and independent of any previous ED treatment
  • - Exclusion according to US PI

Trial summary

Enrollment Goal
30825
Trial Dates
October 2003 - September 2004
Phase
Phase 4
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
United States

Primary Outcome

  • Improvement of Erectile Disfunction
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Onset of Drug Effect
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Second successful intercourse
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • General Safety Parameters
    date_rangeTime Frame:
    8 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

REALISE Levitra® - Real Life Safety and Efficacy of Levitra
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

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.