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A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Levitra (Vardenafil, BAY38-9456)

Placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, Vardenafil, Onset of action

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Males with ED for more than 6 months according to the NIH Consensus statement(inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance)
Heterosexual relationship
18 years and older

Exclusion Criteria:

Primary hypoactive sexual desire
History of myocardial infarction, stroke or life threatening arrhythmia within the prior 6 months
Nitrates or nitric oxide donors use
Other exclusion criteria according to the US Product Information

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Outcomes

Primary Outcome Measures

- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration leading to completion of successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP 3)

Secondary Outcome Measures

- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration as measured by Sexual Encounter Profile Question 2 (SEP 2).

- The erectile function (EF) domain score of the International Index of Erectile Function (IIEF) calculated as the sum of scores from Questions 1-5 and 15 at Week 4 as well as all other IIEF factor subscores.

- Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration.

- Other diary questions

- Safety and tolerability

Full Information

NCT ID

NCT00665496

First Posted

April 23, 2008

Last Updated

December 15, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00665496

Brief Title

A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction

Official Title

A Randomized, Double Blind, Double Dummy, Parallel Group, Multi-center Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

June 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2003 (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

This purpose of the study was to evaluate the earliest time to onset of action in adults with erectile dysfunction (often called impotence). In this study vardenafil has been compared to placebo. Patients were asked to fill in questionnaires and a diary in which they filled in details about attempts at sexual activity during study period. Patients received also a stopwatch to record the time of onset of erection. Stopwatch should be started immediately prior to initiating sexual activity and stopped when an erection perceived to be adequate for penetration was obtained.

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, Onset of action

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

732 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Levitra (Vardenafil, BAY38-9456)

Intervention Description

Vardenafil 10 mg and 20 mg orally once a day as needed

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching Placebo

Primary Outcome Measure Information:

Title

Time Frame

First four doses with successful intercourse

Secondary Outcome Measure Information:

Title

- Earliest elapsed time from dosing to attainment of an erection perceived to be adequate for penetration as measured by Sexual Encounter Profile Question 2 (SEP 2).

Time Frame

among the first four doses

Title

Time Frame

among the first four doses

Title

- Responder time to onset, where onset is time from dosing to attainment of an erection perceived to be adequate for penetration.

Time Frame

among the first four doses

Title

- Other diary questions

Time Frame

among the first four doses

Title

- Safety and tolerability

Time Frame

within the study duration

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males with ED for more than 6 months according to the NIH Consensus statement(inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance) Heterosexual relationship 18 years and older Exclusion Criteria: Primary hypoactive sexual desire History of myocardial infarction, stroke or life threatening arrhythmia within the prior 6 months Nitrates or nitric oxide donors use Other exclusion criteria according to the US Product Information

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90212

Country

United States

City

San Bernardino

State/Province

California

ZIP/Postal Code

92404

Country

United States

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80012

Country

United States

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32257

Country

United States

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

City

Lawrenceville

State/Province

New Jersey

ZIP/Postal Code

08648

Country

United States

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28209

Country

United States

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3G 3J9

Country

Canada

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3T 5J3

Country

Canada

City

St. John

State/Province

New Brunswick

ZIP/Postal Code

E2L 3J8

Country

Canada

City

Kentville

State/Province

Nova Scotia

ZIP/Postal Code

B4N 4K9

Country

Canada

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 4S5

Country

Canada

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4C 3E7

Country

Canada

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

City

Carpentras

ZIP/Postal Code

84200

Country

France

City

Lille

ZIP/Postal Code

59000

Country

France

City

Lyon Cedex

ZIP/Postal Code

69437

Country

France

City

Lyon

ZIP/Postal Code

69000

Country

France

City

Marseille

ZIP/Postal Code

13275

Country

France

City

Montpellier

ZIP/Postal Code

34000

Country

France

City

Nimes

ZIP/Postal Code

30000

Country

France

City

Paris

ZIP/Postal Code

75015

Country

France

City

Garmisch-Partenkirchen

State/Province

Bayern

ZIP/Postal Code

82467

Country

Germany

City

München

State/Province

Bayern

ZIP/Postal Code

80333

Country

Germany

City

München

State/Province

Bayern

ZIP/Postal Code

81925

Country

Germany

City

Marburg

State/Province

Hessen

ZIP/Postal Code

35039

Country

Germany

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30625

Country

Germany

City

Osnabrück

State/Province

Niedersachsen

ZIP/Postal Code

49076

Country

Germany

City

Westerstede

State/Province

Niedersachsen

ZIP/Postal Code

26655

Country

Germany

City

Düsseldorf

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

40210

Country

Germany

City

Mönchengladbach

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

41061

Country

Germany

City

Niederkassel

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53859

Country

Germany

City

Halle

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06097

Country

Germany

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04105

Country

Germany

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

City

Milano

ZIP/Postal Code

20132

Country

Italy

City

Milano

ZIP/Postal Code

20142

Country

Italy

City

Modena

ZIP/Postal Code

41100

Country

Italy

City

Napoli

ZIP/Postal Code

80131

Country

Italy

City

Padova

ZIP/Postal Code

35128

Country

Italy

City

Amsterdam

ZIP/Postal Code

1061 AE

Country

Netherlands

City

Den Haag

ZIP/Postal Code

2512 VA

Country

Netherlands

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

City

Roermond

ZIP/Postal Code

6043 CV

Country

Netherlands

City

Utrecht

ZIP/Postal Code

3514 AB

Country

Netherlands

City

Moelv

ZIP/Postal Code

2390

Country

Norway

City

Oslo

ZIP/Postal Code

0272

Country

Norway

City

Sarpsborg

ZIP/Postal Code

1700

Country

Norway

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

City

Koscierzyna

ZIP/Postal Code

83-400

Country

Poland

City

Lodz

ZIP/Postal Code

91-425

Country

Poland

City

Poznan

ZIP/Postal Code

61-701

Country

Poland

City

Warszawa

ZIP/Postal Code

01-059

Country

Poland

City

Warszawa

ZIP/Postal Code

04-749

Country

Poland

City

Wroclaw

ZIP/Postal Code

54-144

Country

Poland

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

City

L'Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

City

Galdakao

State/Province

Bizkaia

ZIP/Postal Code

48960

Country

Spain

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08025

Country

Spain

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

City

Castellón de la Plana

ZIP/Postal Code

12004

Country

Spain

City

Madrid

ZIP/Postal Code

28040

Country

Spain

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

City

Borås

ZIP/Postal Code

503 32

Country

Sweden

City

Göteborg

ZIP/Postal Code

412 59

Country

Sweden

City

Skövde

ZIP/Postal Code

541 30

Country

Sweden

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

City

Bristol

State/Province

Avon

ZIP/Postal Code

BS10 5NB

Country

United Kingdom

City

Bristol

State/Province

Avon

ZIP/Postal Code

BS2 8HW

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study to Investigate the Time to Onset of Action of 10 mg and 20 mg of Vardenafil Compared to Placebo in Males With Erectile Dysfunction

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