NCT00663130

Brief Summary

Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED

Trial Health

100
On Track

Trial Health Score

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

Enrollment
759

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
3.8 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

October 11, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

April 17, 2008

Last Update Submit

October 9, 2013

Conditions

Erectile Dysfunction

Keywords

Erectile DysfunctionVardenafil

Outcome Measures

Primary Outcomes (1)

  • Sexual Encounter Profile Question 3 (SEP-3)

    4 weeks

Secondary Outcomes (5)

  • Sexual Encounter Profile Question 2 (SEP-2)

    4 weeks

  • International Index of Erectile Function

    4 weeks

  • Global Confidence Question (GCQ)

    4 weeks

  • Erection Quality Scale (EQS)

    4 weeks

  • General Safety

    4 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

ACTIVE COMPARATOR
Drug: Tadalafil

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse

Arm 1
TadalafilDRUG

Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse

Arm 2

Eligibility Criteria

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

You may qualify if:

  • Age between 18 and 64 years
  • Heterosexual males
  • Erectile dysfunction for more than 6 months

You may not qualify if:

  • Penile anatomical abnormalities
  • Spinal cord injury
  • History of surgical prostatectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Vardenafil DihydrochlorideTadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazinesCarbolinesPyridinesIndole AlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 22, 2008

Study Start

April 1, 2004

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

October 11, 2013

Record last verified: 2013-10