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BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Levitra (Vardenafil, BAY38-9456)

Placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Vardenafil, Erectile dysfunction, SSES-E (sexual self-efficacy scale - erectile function)

Eligibility Criteria

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

Inclusion Criteria:

Men with heterosexual relationships aged 18 - 64 years suffering from ED for more than 6 months according to the NIH Consensus Statement (i.e. inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance).
At least 4 attempts at sexual intercourse (according to the question in the subject diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary.

Exclusion Criteria:

Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease) that in the investigator's opinion would significantly impair sexual performance.
Primary hypoactive sexual desire.-Spinal cord injury-History of surgical prostatectomy (transurethral interventions not excluded).
Unstable angina pectoris.
History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months.
Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate >100 BPM).

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

LOCF improved compared to baseline GAQ results at the end of the study

Secondary Outcome Measures

IIEF scores

OF, SD, IS scores in IIEF Questionnaire

Scores of all individual questions on IIEF questionnaire

Subject's diary response

SSES-E scores

Summary score from the responses to SSES-E

Response scores and summary score from the responses to the SF-36

Full Information

NCT ID

NCT00665054

First Posted

April 18, 2008

Last Updated

December 23, 2014

Sponsor

Bayer

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00665054

Brief Title

BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction

Official Title

Multi-centre, Randomized, Double-blind, Parallel, Placebo-controlled Clinical Study to Assess the Efficacy and Tolerability of Vardenafil and Its Influence on Self-esteem and Self Confidence in Subjects With Erectile Dysfunction.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

August 2005 (Actual)

Study Completion Date

August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Purpose of the study is:- To assess the efficacy and tolerability of vardenafil in male subjects suffering from erectile dysfunction as compared to placebo- To assess the influence of vardenafil on the self-esteem and self-confidence of subjects suffering from erectile dysfunction following treatment with vardenafil as compared to placebo

6. Conditions and Keywords

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

Erectile Dysfunction

Keywords

Vardenafil, Erectile dysfunction, SSES-E (sexual self-efficacy scale - erectile function)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

160 (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, 10, or 20 mg Vardenafil tablets orally prior to sexual activity

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo tablets orally prior to sexual activity

Primary Outcome Measure Information:

Title

LOCF improved compared to baseline GAQ results at the end of the study

Time Frame

baseline versus visit 2 visit 5 or premature termination visit

Secondary Outcome Measure Information:

Title

IIEF scores

Time Frame

visits 3, 4 and 5

Title

OF, SD, IS scores in IIEF Questionnaire

Time Frame

visits 2, 3, 4, 5 or at premature termination visit

Title

Scores of all individual questions on IIEF questionnaire

Time Frame

visits 2, 3, 4, 5 or at premature termination visit

Title

Subject's diary response

Time Frame

baseline and after randomization per visit period

Title

SSES-E scores

Time Frame

visits 2 and 5 or premature termination visit

Title

Summary score from the responses to SSES-E

Time Frame

visits 2 and 5 or premature termination visit

Title

Response scores and summary score from the responses to the SF-36

Time Frame

visits 2 and 5 or premature termination visit

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: Men with heterosexual relationships aged 18 - 64 years suffering from ED for more than 6 months according to the NIH Consensus Statement (i.e. inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance). At least 4 attempts at sexual intercourse (according to the question in the subject diary) on 4 separate days during the 4-week untreated baseline period. At least 50% of attempts during this period had to be unsuccessful according to the subject diary. Exclusion Criteria: Presence of penile anatomical abnormalities (eg penile fibrosis or Peyronie's disease) that in the investigator's opinion would significantly impair sexual performance. Primary hypoactive sexual desire.-Spinal cord injury-History of surgical prostatectomy (transurethral interventions not excluded). Unstable angina pectoris. History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months. Uncontrolled atrial fibrillation/flutter at screening visit (ventricular response rate >100 BPM).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Adana

ZIP/Postal Code

01330

Country

Turkey

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

City

Antalya

ZIP/Postal Code

07003

Country

Turkey

City

Istanbul

ZIP/Postal Code

34098

Country

Turkey

City

Istanbul

ZIP/Postal Code

34662

Country

Turkey

City

Izmir

ZIP/Postal Code

35340

Country

Turkey

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

12. IPD Sharing Statement

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BAY38-9456, 5/10/20mg, vs.Placebo in Erectile Dysfunction

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