Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Vardenafil (Levitra, BAY38-9456)

Placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Vardenafil, Erectile Dysfunction, Double-blind study

Eligibility Criteria

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

Inclusion Criteria:

Stable heterosexual relationship
History of erectile dysfunction for at least 6 months
IIEF- EF Domain entry score (at Visit 2): >21 points
Documented metabolic syndrome according to the IDF (International Diabetes Foundation)
Subjects motivated for erectile dysfunction treatment
Documented, dated, written informed consent

Exclusion Criteria:

Any underlying cardiovascular condition
History of myocardial infarction
Uncontrolled atrial fibrillation
Resting hypotension
Postural hypotension within 6 months of Visit 1
History of congenital QT prolongation
Bleeding disorder
History of prostatectomy because of prostate cancer
Hereditary degenerative retinal disorders
History of loss of vision because of NAION (non-arteritic anterior ischemic optic neuropathy)
29 Additional Exclusion Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vardenafil (Levitra, BAY38-9456)

Placebo

Arm Description

Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks

Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)

The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction [ED]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward [LOCF]) as calculated via an ANCOVA.

Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8

Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants.

Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8

Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants.

Secondary Outcome Measures

Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)

Responders: percentage of participants achieving an IIEF-EF score >25.(IIEF-EF domain score: 6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no ED')

Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8

Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants.

Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8

Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants.

Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))

Number of participants with no recorded titration of Vardenafil after visit 3.

Full Information

NCT ID

NCT00738400

First Posted

August 19, 2008

Last Updated

November 12, 2015

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00738400

Brief Title

Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome

Official Title

Double-blind, Placebo Controlled, Randomized Study of Vardenafil to Determine Efficacy on Erectile Dysfunction (ED) in Men With ED and Metabolic Syndrome (ED-METABOLIC)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)

6. Conditions and Keywords

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

Erectile Dysfunction, Metabolic Syndrome

Keywords

Vardenafil, Erectile Dysfunction, Double-blind study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vardenafil (Levitra, BAY38-9456)

Arm Type

Experimental

Arm Description

Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks

Intervention Type

Drug

Intervention Name(s)

Vardenafil (Levitra, BAY38-9456)

Intervention Description

Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks

Primary Outcome Measure Information:

Title

Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF)

Description

The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction [ED]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward [LOCF]) as calculated via an ANCOVA.

Time Frame

baseline and up to 8 weeks or LOCF

Title

Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8

Description

Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants.

Time Frame

Baseline and 8 weeks

Title

Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8

Description

Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants.

Time Frame

Baseline and 8 weeks

Secondary Outcome Measure Information:

Title

Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF)

Description

Responders: percentage of participants achieving an IIEF-EF score >25.(IIEF-EF domain score: 6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no ED')

Time Frame

up to 8 weeks or LOCF

Title

Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8

Description

Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants.

Time Frame

Baseline and 8 weeks

Title

Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8

Description

Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants.

Time Frame

Baseline and 8 weeks

Title

Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata))

Description

Number of participants with no recorded titration of Vardenafil after visit 3.

Time Frame

week 4 and week 8

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Stable heterosexual relationship History of erectile dysfunction for at least 6 months IIEF- EF Domain entry score (at Visit 2): >21 points Documented metabolic syndrome according to the IDF (International Diabetes Foundation) Subjects motivated for erectile dysfunction treatment Documented, dated, written informed consent Exclusion Criteria: Any underlying cardiovascular condition History of myocardial infarction Uncontrolled atrial fibrillation Resting hypotension Postural hypotension within 6 months of Visit 1 History of congenital QT prolongation Bleeding disorder History of prostatectomy because of prostate cancer Hereditary degenerative retinal disorders History of loss of vision because of NAION (non-arteritic anterior ischemic optic neuropathy) 29 Additional Exclusion Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Cham

State/Province

Bayern

ZIP/Postal Code

93413

Country

Germany

City

Regensburg

State/Province

Bayern

ZIP/Postal Code

93055

Country

Germany

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60385

Country

Germany

City

Marburg

State/Province

Hessen

ZIP/Postal Code

35039

Country

Germany

City

Stuhr

State/Province

Niedersachsen

ZIP/Postal Code

28816

Country

Germany

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53119

Country

Germany

City

Grevenbroich

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

41515

Country

Germany

City

Leverkusen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

51373

Country

Germany

City

Mülheim

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45468

Country

Germany

City

Wuppertal

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

42103

Country

Germany

City

Dierdorf

State/Province

Rheinland-Pfalz

ZIP/Postal Code

56269

Country

Germany

City

Koblenz

State/Province

Rheinland-Pfalz

ZIP/Postal Code

56068

Country

Germany

City

Trier

State/Province

Rheinland-Pfalz

ZIP/Postal Code

54290

Country

Germany

City

Homburg

State/Province

Saarland

ZIP/Postal Code

66424

Country

Germany

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01307

Country

Germany

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04109

Country

Germany

City

Berlin

ZIP/Postal Code

12107

Country

Germany

City

Berlin

ZIP/Postal Code

14197

Country

Germany

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

21771281

Citation

Schneider T, Gleissner J, Merfort F, Hermanns M, Beneke M, Ulbrich E. Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial. J Sex Med. 2011 Oct;8(10):2904-11. doi: 10.1111/j.1743-6109.2011.02383.x. Epub 2011 Jul 19.

Results Reference

result

Links:

URL

http://www.clinicaltrialsregister.eu/

Description

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

Erectile Dysfunction, Metabolic Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial