NCT00668018

Brief Summary

Assess efficacy of vardenafil within 6 hours after intake

Trial Health

100
On Track

Trial Health Score

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

Enrollment
887

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

April 24, 2008

Last Update Submit

December 18, 2014

Conditions

Erectile Dysfunction

Keywords

Male Erectile DysfunctionVardenafil

Outcome Measures

Primary Outcomes (1)

  • Successful attempt rate reported between drug ingestion and a maximum of 6 hours after drug intake

    12 weeks

Secondary Outcomes (4)

  • International Index of Erectile Function

    12 weeks

  • Global Assessment Question (GAQ)

    12 weeks

  • Other diary responses

    12 weeks

  • General Safety

    12 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL
Drug: Levitra (Vardenafil, BAY38-9456)

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

Vardenafil 10mg orally on demand prior to intercourse

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Age: 18 years and older
  • Males with erectile dysfunction
  • Stable heterosexual relationship

You may not qualify if:

  • Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
  • Nitrate use

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

Study Record Dates

First Submitted

April 24, 2008

First Posted

April 28, 2008

Study Start

January 1, 2003

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

December 23, 2014

Record last verified: 2014-12