NCT00661297

Brief Summary

Study to investigate the efficacy and safety of Vardenafil

Trial Health

100
On Track

Trial Health Score

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

Enrollment
523

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 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

June 1, 2003

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

April 15, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

First QC Date

April 15, 2008

Last Update Submit

December 1, 2014

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionVardenafil

Outcome Measures

Primary Outcomes (1)

  • Sexual Encounter Profile question 2 (SEP 2)

    12 weeks

Secondary Outcomes (3)

  • Sexual Encounter Profile question 3 (SEP 3)

    12 weeks

  • International Index of Erectile Function (IIEF) - EF (Erectile Function) domain

    12 weeks

  • Safety and Tolerability

    12 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

10 mg Vardenafil to be taken 1 h prior to sexual attempt

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:

  • Heterosexual males
  • \>/= 18 years old with ED for more than six months
  • Subjects also needed a positive first-time response to a single dose of 10mg vardenafil to be eligible for randomisation

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 15, 2008

First Posted

April 18, 2008

Study Start

June 1, 2003

Study Completion

January 1, 2004

Last Updated

December 2, 2014

Record last verified: 2014-12