NCT00681772

Brief Summary

Erectile dysfunction (ED) is defined as the inability to achieve or maintain an erection sufficient for satisfactory sexual performance. An ideal treatment option should be effective and reliable, have minimal side effects, be simple to use and affordable. The aim of this study was to investigate safety, tolerability and efficacy of vardenafil following a flexible dose treatment schedule in subjects with varying aetiology.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
333

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 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

March 1, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2003

Completed
4.5 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

December 11, 2014

Status Verified

December 1, 2014

First QC Date

April 18, 2008

Last Update Submit

December 10, 2014

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionVardenafil

Outcome Measures

Primary Outcomes (1)

  • International Index of Erectile Function - Erectile Function Domain

    12 weeks

Secondary Outcomes (4)

  • Sexual Encounter Profile Question 2 and 3

    12 weeks

  • Global Assessment Question

    12 weeks

  • Other diary based variables

    12 weeks

  • Safety and tolerability

    12 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Levitra (Vardenafil, BAY38-9456)

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

5mg, 10mg or 20mg taken 1 hours before sexual intercourse

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Men \>/= 18 years of age,
  • ED 6 months or longer
  • 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 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 18, 2008

First Posted

May 21, 2008

Study Start

March 1, 2003

Study Completion

November 1, 2003

Last Updated

December 11, 2014

Record last verified: 2014-12