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Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)

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ClinicalTrials.gov Identifier: NCT00665340
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : October 11, 2013
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE April 18, 2008
First Posted Date  ICMJE April 23, 2008
Last Update Posted Date October 11, 2013
Study Start Date  ICMJE July 2004
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2008)
Erection Quality Scale [ Time Frame: Week 8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2008)
  • Erection Quality Scale [ Time Frame: Week 4 and 8 ]
  • International Index of Erectile Function- Erectile Function domain score [ Time Frame: Week 4 and 8 ]
  • Per-subject success rates based on Sexual Encounter Profile, Question 2 [ Time Frame: Week 4, 8 Week 8 ]
  • Safety and tolerability [ Time Frame: Week 8 ]
  • Patient Diary Questions [ Time Frame: Weeks 4, 8 Week 8 ]
  • Global Assessment Question (GAQ) [ Time Frame: Weeks 4, 8 of treatment and Week 8 ]
  • Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25) [ Time Frame: Week 8-LOCF ]
  • Penetration (SEP2) and Maintenance (SEP3) reliability [ Time Frame: Week 8-LOCF ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)
Official Title  ICMJE A Randomized, Double Blind, Placebo-controlled, Parallel Group, Multi-center Study to Investigate the Responsiveness of the Erectile Quality Scale (EQS) to Vardenafil HCl Flexible Dose Versus Placebo in Males With Erectile Dysfunction.
Brief Summary This study was conducted to evaluate in adult men with erectile dysfunction (often called impotence), the effect of vardenafil HCl on the quality of their erections. Many men experience occasional erectile problems during their lives. The causes of erectile dysfunction are varied and may be due to physiological or emotional reasons. This study is designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl. In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like the real drug but it is not. It contains no active ingredients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE
  • Drug: Placebo
    Matching placebo
  • Drug: Levitra (Vardenafil, BAY38-9456)
    5m, 10 mg and 20 mg 1 h prior to sexual intercourse
Study Arms  ICMJE
  • Placebo Comparator: Arm 1
    Intervention: Drug: Placebo
  • Experimental: Arm 2
    Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2008)
219
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2005
Actual Primary Completion Date January 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Inclusion Criteria:- Males who have had ED for at least six months- Heterosexual relationship.- Males 18 and older. Exclusion Criteria:- Primary hypoactive sexual desire.- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.- Stable heterosexual relationship for > 6 month- Other exclusion criteria apply according to the US Product Information
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00665340
Other Study ID Numbers  ICMJE 11561
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP