NCT00663728

Brief Summary

This study assessed the effect of 10mg vardenafil, taken on demand in an 'at home' setting, as compared to placebo (dummy medication with no pharmacological activity), on the duration of erection from the moment when the patient perceived his erection to be hard enough for penetration until withdrawal from the partner's vagina leading to successful completion which may or may not have included ejaculation. The patient used the stopwatch for the above assessments. The efficacy of oral ED treatments is measured by questionnaires and patient diaries.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2004

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
3 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 30, 2014

Status Verified

December 1, 2014

Enrollment Period

7 months

First QC Date

April 17, 2008

Last Update Submit

December 26, 2014

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionVardenafil

Outcome Measures

Primary Outcomes (1)

  • Effect of vardenafil on the duration of erection

    4 weeks

Secondary Outcomes (1)

  • Perception of erection to be hard enough for penetration

    4 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

10mg Vardenafil taken orally 1 hour prior to sexual intercourse

Arm 1
PlaceboDRUG

Matching placebo

Arm 2

Eligibility Criteria

Age18 Years - 64 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 22, 2008

Study Start

September 1, 2004

Primary Completion

April 1, 2005

Study Completion

April 1, 2005

Last Updated

December 30, 2014

Record last verified: 2014-12