Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00665340
NCT00665340CompletedPhase 4

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.

Bayer0 sites219 target enrollmentStarted: July 2004Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Bayer
Enrollment
219
Primary Endpoint
Erection Quality Scale
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

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

Arms & Interventions

Arm 1

Placebo Comparator

Intervention: Placebo (Drug)

Arm 2

Experimental

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug)

Outcomes

Primary Outcomes

Erection Quality Scale

Time Frame: Week 8

Secondary Outcomes

  • Erection Quality Scale(Week 4 and 8)
  • International Index of Erectile Function- Erectile Function domain score(Week 4 and 8)
  • Patient Diary Questions(Weeks 4, 8 Week 8)
  • Penetration (SEP2) and Maintenance (SEP3) reliability(Week 8-LOCF)
  • Per-subject success rates based on Sexual Encounter Profile, Question 2(Week 4, 8 Week 8)
  • Safety and tolerability(Week 8)
  • Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25)(Week 8-LOCF)
  • Global Assessment Question (GAQ)(Weeks 4, 8 of treatment and Week 8)

Investigators

Sponsor
Bayer
Sponsor Class
Industry
Responsible Party
Sponsor

Similar Trials

Active, not recruiting
Phase 1
A controlled drug trial for 12 weeks plus another 4 weeks to test if Elobixibat 5 and 10 mg helps and is safe for patients with chronic constipatioChronic idiopathic constipationMedDRA version: 17.0Level: LLTClassification code 10072118Term: Chronic idiopathic constipationSystem Organ Class: 100000004856
EUCTR2012-005588-28-CZFerring International Pharmascience Center US, Inc.840
Active, not recruiting
Phase 1
A study to investigate the efficacy and safety of selepressin as treatment for patients with septic shock that need vasopressor treatmentVasopressor-dependent Septic ShockMedDRA version: 18.1Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestations
EUCTR2014-003973-41-NLFerring Pharmaceuticals A/S1,800
Active, not recruiting
Not Applicable
A controlled drug trial for 12 weeks plus another 4 weeks to test if Elobixibat 5 and 10 mg helps and is safe for patients with chronic constipatio
EUCTR2012-005588-28-SEFerring International Pharmascience Center US, Inc.840
Completed
Phase 2
A Double-blind, Randomised, Placebo-controlled, Phase 2b/3 Adaptive Clinical Trial Investigating the Efficacy and Safety of Selepressin as Treatment for Patients with Vasopressor-dependent Septic ShockshockVasopressor-dependent septic shock10011954
NL-OMON43990Ferring225
Active, not recruiting
Not Applicable
A controlled drug trial for 12 weeks plus another 4 weeks to test if Elobixibat 5 and 10 mg helps and is safe for patients with chronic constipatio
EUCTR2012-005588-28-DEFerring International Pharmascience Center US, Inc.840