check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

100497

ClinicalTrials.gov Identifier:

NCT00658177

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study Evaluating the Efficacy and Safety of flexible-dose Vardenafil in subjects with erectile dysfunction

Trial purpose

Study to investigate the efficacy and safety of Vardenafil

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,
    - History of unresponsiveness to sildenafil
    - 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
    - Other exclusion criteria apply according to the US Product Information

Trial summary

Enrollment Goal
463
Trial Dates
June 2003 - February 2004
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Primary Outcome

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

Secondary Outcome

  • Sexual Encounter Profile Question 3
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Internation 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 Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects
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.