Trial Condition(s):
Erectile Dysfunction
Investigate the responsiveness of the Erectile Quality Scale to vardenafil flexible dose vs placebo in males with Erectile Dysfunction (ED)
Bayer Identifier:
11561
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Hudson Valley Urology Center Poughkeepsie, United States, 12601 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Havover Medical Research Associates Wilmington, United States, 28401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Lipid Center Statesville, United States, 28677 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lawrenceville Urology Lawrenceville, United States, 08648 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations California Professional Research Newport Beach, United States, 92660 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research Consultants, Inc. Trumbull, United States, 06611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Florida Medical Research Aventura, United States, 33180 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Arizona Research Center, Inc. Phoenix, United States, 85023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urology Research Options Aurora, United States, 80012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Male Clinic Beverly Hills, United States, 90212 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Research Associates, Inc. Nashville, United States, 37203 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations South Coast Urological Medical Group Laguna Hills, United States, 92653 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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.
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Erection Quality ScaleTimeframe: Week 8
Secondary Outcome
- Erection Quality ScaleTimeframe: Week 4 and 8
- International Index of Erectile Function- Erectile Function domain scoreTimeframe: Week 4 and 8
- Per-subject success rates based on Sexual Encounter Profile, Question 2Timeframe: Week 4, 8 Week 8
- Safety and tolerabilityTimeframe: Week 8
- Patient Diary QuestionsTimeframe: Weeks 4, 8 Week 8
- Global Assessment Question (GAQ)Timeframe: Weeks 4, 8 of treatment and Week 8
- Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25)Timeframe: Week 8-LOCF
- Penetration (SEP2) and Maintenance (SEP3) reliabilityTimeframe: Week 8-LOCF
Additional Information
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