check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

11333

ClinicalTrials.gov Identifier:

NCT00663130

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluating the efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in subjects with erectile dysfunction (ED)

Trial purpose

Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED

Key Participants Requirements

Sex

Male

Age

18 - 64 Years
  • - Age between 18 and 64 years
    - Heterosexual males
    - Erectile dysfunction for more than 6 months
  • - Penile anatomical abnormalities
    - Spinal cord injury
    - History of surgical prostatectomy

Trial summary

Enrollment Goal
759
Trial Dates
April 2004 - July 2004
Phase
Phase 4
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Primary Outcome

  • Sexual Encounter Profile Question 3 (SEP-3)
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Sexual Encounter Profile Question 2 (SEP-2)
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    no
  • International Index of Erectile Function
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Global Confidence Question (GCQ)
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    no
  • Erection Quality Scale (EQS)
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    no
  • General Safety
    date_rangeTime Frame:
    4 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

A randomised, double-blind, double-dummy, parallel-group, active-controlled study evaluating the efficacy of vardenafil versus tadalafil when intercourse is attempted within 45 minutes of administration in subjects with 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.