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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00665340
Other study ID # 11561
Secondary ID
Status Completed
Phase Phase 4
First received April 18, 2008
Last updated October 10, 2013
Start date July 2004
Est. completion date January 2005

Study information

Verified date October 2013
Source Bayer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 219
Est. completion date January 2005
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 64 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Matching placebo
Levitra (Vardenafil, BAY38-9456)
5m, 10 mg and 20 mg 1 h prior to sexual intercourse

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Erection Quality Scale Week 8 No
Secondary Erection Quality Scale Week 4 and 8 No
Secondary International Index of Erectile Function- Erectile Function domain score Week 4 and 8 No
Secondary Per-subject success rates based on Sexual Encounter Profile, Question 2 Week 4, 8 Week 8 No
Secondary Safety and tolerability Week 8 Yes
Secondary Patient Diary Questions Weeks 4, 8 Week 8 No
Secondary Global Assessment Question (GAQ) Weeks 4, 8 of treatment and Week 8 No
Secondary Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25) Week 8-LOCF No
Secondary Penetration (SEP2) and Maintenance (SEP3) reliability Week 8-LOCF No
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