NCT00786253

Brief Summary

Compare once daily vs on demand treatment in men with erectile dysfunction. Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out: A: once daily at bedtime for 12 weeks followed by 12 weeks of placebo B: once daily at bedtime for 24 weeksC: PRN for 24 weeks

Trial Health

87
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

19 active sites

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

October 1, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
9 months until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

First QC Date

February 25, 2008

Last Update Submit

October 27, 2014

Conditions

Erectile Dysfunction

Keywords

Erectile dysfunctionVardenafil

Outcome Measures

Primary Outcomes (1)

  • Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF)

    12- 24 weeks

Secondary Outcomes (2)

  • SEP 2

    12- 24 weeks

  • SEP 3

    12- 24 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

EXPERIMENTAL
Drug: Levitra (Vardenafil, BAY38-9456)

Interventions

Levitra (Vardenafil, BAY38-9456)DRUG

Vardenafil 10 mg on demand use

Arm 1

Eligibility Criteria

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

You may qualify if:

  • Males 18-64 years of age
  • Mild or mild to moderate ED (defined as \>15 and \<21 score points according to the Erectile Function Domain Score from IIEF as assessed at the randomisation visit)
  • History of at least one of the following conditions: Diabetes mellitus type 2, hypertension, peripheral arterial occlusive disease
  • Stable, heterosexual relationship for more than six months

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

Study Sites (19)

Unknown Facility

Tübingen, Baden-Württemberg / 277, 72076, Germany

Location

Unknown Facility

München, Bayern / 280, 81925, Germany

Location

Unknown Facility

Regensburg, Bayern / 280, 93053, Germany

Location

Unknown Facility

Weiden, Bayern / 280, 92637, Germany

Location

Unknown Facility

Berlin, Berlin / 285, 12200, Germany

Location

Unknown Facility

Hamburg, Hamburg / 287, 20251, Germany

Location

Unknown Facility

Hamburg, Hamburg / 287, 20354, Germany

Location

Unknown Facility

Hamburg, Hamburg / 287, 22299, Germany

Location

Unknown Facility

Marburg, Hessen / 307, 35039, Germany

Location

Unknown Facility

Hagenow, Mecklenburg-Vorpommern / 309, 19230, Germany

Location

Unknown Facility

Hanover, Niedersachsen / 291, 30625, Germany

Location

Unknown Facility

Osnabrück, Niedersachsen / 293, 49076, Germany

Location

Unknown Facility

Düsseldorf, Nordrhein-Westfalen / 296, 40225, Germany

Location

Unknown Facility

Münster, Nordrhein-Westfalen / 298, 48149, Germany

Location

Unknown Facility

Leverkusen, Nordrhein-Westfalen / 331, 51375, Germany

Location

Unknown Facility

Grevenbroich, Nordrhein-Westfalen / 623, 41515, Germany

Location

Unknown Facility

Leipzig, Sachsen / 313, 04249, Germany

Location

Unknown Facility

Meißen, Sachsen / 313, 01662, Germany

Location

Unknown Facility

Halle, Sachsen-Anhalt / 311, 06097, Germany

Location

Related Links

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 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2008

First Posted

November 6, 2008

Study Start

October 1, 2005

Study Completion

January 1, 2007

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations

DE(19)