Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

October 27, 2014 updated by: Bayer

A Randomized, Explorative, Double-blind, Double-dummy, Multi-center, Parallel Group Study to Assess Sustainable Efficacy of Once Daily Vardenafil (10 mg) for 12 and 24 Weeks Versus Vardenafil PRN in Men With Mild or Mild to Moderate ED

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg / 277
      • Tübingen, Baden-Württemberg / 277, Germany, 72076
    • Bayern / 280
      • München, Bayern / 280, Germany, 81925
      • Regensburg, Bayern / 280, Germany, 93053
      • Weiden, Bayern / 280, Germany, 92637
    • Berlin / 285
      • Berlin, Berlin / 285, Germany, 12200
    • Hamburg / 287
      • Hamburg, Hamburg / 287, Germany, 20251
      • Hamburg, Hamburg / 287, Germany, 20354
      • Hamburg, Hamburg / 287, Germany, 22299
    • Hessen / 307
      • Marburg, Hessen / 307, Germany, 35039
    • Mecklenburg-Vorpommern / 309
      • Hagenow, Mecklenburg-Vorpommern / 309, Germany, 19230
    • Niedersachsen / 291
      • Hannover, Niedersachsen / 291, Germany, 30625
    • Niedersachsen / 293
      • Osnabrück, Niedersachsen / 293, Germany, 49076
    • Nordrhein-Westfalen / 296
      • Düsseldorf, Nordrhein-Westfalen / 296, Germany, 40225
    • Nordrhein-Westfalen / 298
      • Münster, Nordrhein-Westfalen / 298, Germany, 48149
    • Nordrhein-Westfalen / 331
      • Leverkusen, Nordrhein-Westfalen / 331, Germany, 51375
    • Nordrhein-Westfalen / 623
      • Grevenbroich, Nordrhein-Westfalen / 623, Germany, 41515
    • Sachsen / 313
      • Leipzig, Sachsen / 313, Germany, 04249
      • Meißen, Sachsen / 313, Germany, 01662
    • Sachsen-Anhalt / 311
      • Halle, Sachsen-Anhalt / 311, Germany, 06097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg on demand use
Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil daily dosing 10 mg
Experimental: Arm 2
Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg on demand use
Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil daily dosing 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Erectile Dysfunction change score from baseline of the ED change score from baseline of the International Index of Erectile Function (IIEF-EF)
Time Frame: 12- 24 weeks
12- 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
SEP 2
Time Frame: 12- 24 weeks
12- 24 weeks
SEP 3
Time Frame: 12- 24 weeks
12- 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

February 25, 2008

First Submitted That Met QC Criteria

November 5, 2008

First Posted (Estimate)

November 6, 2008

Study Record Updates

Last Update Posted (Estimate)

October 28, 2014

Last Update Submitted That Met QC Criteria

October 27, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11875 (DAIDS-ES)
  • RESTORE
  • EudraCT No: 2005-001678-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Erectile Dysfunction

Clinical Trials on Levitra (Vardenafil, BAY38-9456)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe