NCT00663598

Brief Summary

Collect data on safety, efficacy, and subject acceptance of vardenafil treatment under daily life conditions in a large number of subjects with erectile dysfunction (ED)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30,825

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_4

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, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

First QC Date

April 17, 2008

Last Update Submit

December 18, 2014

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionVardenafil

Outcome Measures

Primary Outcomes (3)

  • Improvement of Erectile Disfunction

    8 weeks

  • Onset of Drug Effect

    8 weeks

  • Second successful intercourse

    8 weeks

Secondary Outcomes (1)

  • General Safety Parameters

    8 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Levitra (Vardenafil, BAY38-9456)

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

Treatment according to US PI

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Male outpatients \>/= 18 years of age with a diagnosis of ED according to the 1992 US National Institutes of Health (NIH) Consensus Statement (the inability to achieve and maintain penile erection sufficient to complete satisfactory intercourse), and independent of any previous ED treatment

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 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 22, 2008

Study Start

October 1, 2003

Study Completion

September 1, 2004

Last Updated

December 19, 2014

Record last verified: 2014-12