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Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 3

Locations

Spain

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

Eligibility Criteria

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

Inclusion Criteria:

Age: 18 years and older
Males with erectile dysfunction
Stable heterosexual relationship

Exclusion Criteria:

Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
Nitrate use
Other exclusion criteria apply acc. to Summary of Product Characteristics

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

International Index of Erectile Function - Erectile Function Domain

Secondary Outcome Measures

Global Assessment Questionnaire

IIEF-EF domain score

Other diary based variables

Safety and tolerability

Full Information

NCT ID

NCT00661596

First Posted

April 15, 2008

Last Updated

December 28, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00661596

Brief Title

Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction

Official Title

Multi-centre, Randomised, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy of Vardenafil and Its Influence on Self-esteem and Self-confidence in Patients With Erectile Dysfunction

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

January 2004 (Actual)

Study Completion Date

January 2004 (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

Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.

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 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

129 (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

5 mg, 10 mg and 20 mg one hour prior to sexual intercourse

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo

Primary Outcome Measure Information:

Title

International Index of Erectile Function - Erectile Function Domain

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Global Assessment Questionnaire

Time Frame

12 weeks

Title

IIEF-EF domain score

Time Frame

12 weeks

Title

Other diary based variables

Time Frame

12 weeks

Title

Safety and tolerability

Time Frame

12 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: 18 years and older Males with erectile dysfunction Stable heterosexual relationship Exclusion Criteria: Primary hypoactive sexual desire- History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months Nitrate use Other exclusion criteria apply acc. to Summary of Product Characteristics

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33006

Country

Spain

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

City

Barcelona

State/Province

Cataluña

ZIP/Postal Code

08025

Country

Spain

City

Hondarribia

State/Province

Guipuzcoa

ZIP/Postal Code

28280

Country

Spain

City

Leganés

State/Province

Madrid

ZIP/Postal Code

28911

Country

Spain

City

Móstoles

State/Province

Madrid

ZIP/Postal Code

28935

Country

Spain

City

Vigo

State/Province

Pontevedra

ZIP/Postal Code

36211

Country

Spain

City

Alicante

ZIP/Postal Code

03010

Country

Spain

City

Granada

ZIP/Postal Code

18003

Country

Spain

City

Málaga

ZIP/Postal Code

29010

Country

Spain

City

Sevilla

ZIP/Postal Code

41071

Country

Spain

City

Valencia

ZIP/Postal Code

46014

Country

Spain

City

Valladolid

ZIP/Postal Code

47011

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction

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