NCT00656188

Brief Summary

This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
463

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2002

Shorter than P25 for phase_2

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2008

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

Enrollment Period

7 months

First QC Date

April 4, 2008

Last Update Submit

October 9, 2013

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionVardenafil

Outcome Measures

Primary Outcomes (3)

  • Erectile Function domain of the International Index of Erectile Function

    12 weeks

  • Sexual Encounter Profile Question 2

    12 weeks

  • Sexual Encounter Profile Question 3

    12 weeks

Secondary Outcomes (7)

  • Erectile Function domain scores > 26

    12 weeks

  • Sexual Encounter Profile 2

    12 weeks

  • Global Assessment Question

    12 weeks

  • Reliability of insertion

    12 weeks

  • Reliability of maintenance

    12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Arm 1

ACTIVE COMPARATOR
Drug: Levitra (Vardenafil, BAY38-9456)

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to 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 2
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 4, 2008

First Posted

April 10, 2008

Study Start

October 1, 2002

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

October 10, 2013

Record last verified: 2013-10