check_circleStudy Completed

Erectile Dysfunction

Bayer Identifier:

11586

ClinicalTrials.gov Identifier:

NCT00667979

EudraCT Number:

2004-001549-13

EU CT Number:

Not Available
Evaluating the Efficacy of Vardenafil in subjects with Erectile Dysfunction (ED) administered 12, 18 or 24 hours prior to intercourse

Trial purpose

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. However, there remains no prospectively obtained data on the maximal time of effectiveness of vardenafil. The goal of the current study was to determine if vardenafil will significantly increase the percentage of successful intercourse attempts from 12 to 24 hours following dosing. A total of three time points 12, 18, and 24 hours were assessed in this pilot study to better quantify the effect of vardenafil.

Key Participants Requirements

Sex

Male

Age

18 - 64 Years
  • - Men >/= 18 years of age- ED >/= 6 months - Stable sexual relationship for > 6 months
  • - 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 Summary of Product Characteristics

Trial summary

Enrollment Goal
264
Trial Dates
September 2004 - December 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 3
    date_rangeTime Frame:
    6 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Safety and Tolerability
    date_rangeTime Frame:
    6 weeks
    enhanced_encryption
    Safety Issue:
    yes

Trial design

A pilot, randomized, double-blind, placebo-controlled, crossover study evaluating the efficacy and safety of vardenafil versus placebo administered 12, 18 and 24 hours prior to initiation of sexual intercourse in subjects with ED
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 marketed products.