NCT00682019

Brief Summary

The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
383

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
Last Updated

October 14, 2013

Status Verified

October 1, 2013

First QC Date

April 18, 2008

Last Update Submit

October 10, 2013

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionVardenafil

Outcome Measures

Primary Outcomes (1)

  • Per-patient success rates based on Sexual Encounter Profile, Question 3

    10 weeks

Secondary Outcomes (4)

  • Per-subject success rates based on Sexual Encounter Profile, Question 2

    10 weeks

  • International Index of Erectile Function- Erectile Function domain score

    10 weeks

  • Global Assessment Question (GAQ)

    10 weeks

  • Safety and tolerability

    10 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

5mg, 10mg or 20mg taken 8 hours before sexual intercourse

Arm 1
PlaceboDRUG

matching placebo

Arm 2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
  • History of unresponsiveness to sildenafil
  • Stable sexual relationship for \> 6 month.

You may not qualify if:

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2008

First Posted

May 21, 2008

Study Start

December 1, 2003

Study Completion

August 1, 2004

Last Updated

October 14, 2013

Record last verified: 2013-10