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Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Levitra (Vardenafil, BAY38-9456)

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction, Vardenafil

Eligibility Criteria

18 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

SEP 2

SEP 3

Full Information

NCT ID

NCT00786253

First Posted

February 25, 2008

Last Updated

October 27, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00786253

Brief Title

Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

October 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

Erectile dysfunction, Vardenafil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

236 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Levitra (Vardenafil, BAY38-9456)

Intervention Description

Vardenafil 10 mg on demand use

Intervention Type

Drug

Intervention Name(s)

Levitra (Vardenafil, BAY38-9456)

Intervention Description

Vardenafil daily dosing 10 mg

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

SEP 2

Time Frame

12- 24 weeks

Title

SEP 3

Time Frame

12- 24 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Tübingen

State/Province

Baden-Württemberg / 277

ZIP/Postal Code

72076

Country

Germany

City

München

State/Province

Bayern / 280

ZIP/Postal Code

81925

Country

Germany

City

Regensburg

State/Province

Bayern / 280

ZIP/Postal Code

93053

Country

Germany

City

Weiden

State/Province

Bayern / 280

ZIP/Postal Code

92637

Country

Germany

City

Berlin

State/Province

Berlin / 285

ZIP/Postal Code

12200

Country

Germany

City

Hamburg

State/Province

Hamburg / 287

ZIP/Postal Code

20251

Country

Germany

City

Hamburg

State/Province

Hamburg / 287

ZIP/Postal Code

20354

Country

Germany

City

Hamburg

State/Province

Hamburg / 287

ZIP/Postal Code

22299

Country

Germany

City

Marburg

State/Province

Hessen / 307

ZIP/Postal Code

35039

Country

Germany

City

Hagenow

State/Province

Mecklenburg-Vorpommern / 309

ZIP/Postal Code

19230

Country

Germany

City

Hannover

State/Province

Niedersachsen / 291

ZIP/Postal Code

30625

Country

Germany

City

Osnabrück

State/Province

Niedersachsen / 293

ZIP/Postal Code

49076

Country

Germany

City

Düsseldorf

State/Province

Nordrhein-Westfalen / 296

ZIP/Postal Code

40225

Country

Germany

City

Münster

State/Province

Nordrhein-Westfalen / 298

ZIP/Postal Code

48149

Country

Germany

City

Leverkusen

State/Province

Nordrhein-Westfalen / 331

ZIP/Postal Code

51375

Country

Germany

City

Grevenbroich

State/Province

Nordrhein-Westfalen / 623

ZIP/Postal Code

41515

Country

Germany

City

Leipzig

State/Province

Sachsen / 313

ZIP/Postal Code

04249

Country

Germany

City

Meißen

State/Province

Sachsen / 313

ZIP/Postal Code

01662

Country

Germany

City

Halle

State/Province

Sachsen-Anhalt / 311

ZIP/Postal Code

06097

Country

Germany

12. IPD Sharing Statement

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Learn more about this trial

Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

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