To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00661115

First received: April 15, 2008

Last updated: June 19, 2009

Last verified: June 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

April 15, 2008

Last Updated Date

June 19, 2009

Start Date ^ICMJE

May 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15 [ Time Frame: At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00661115 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Success in penetration and maintenance as recorded in subject diaries [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ] [ Designated as safety issue: No ]
Scores for questions 3 and 4 of the IIEF [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ] [ Designated as safety issue: No ]
Other IIEF domain scores [ Time Frame: At Week 12 (observed and at LOCF) ] [ Designated as safety issue: No ]
Global Assessment Question (GAQ) responses [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ] [ Designated as safety issue: No ]
Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use. [ Time Frame: At Weeks 4, 8 and 12 (as observed and at LOCF) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.

Official Title ^ICMJE

A Randomised, Double Blind, Placebo Controlled, Multi-Center, Fixed Dose, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil (BAY 38-9456) in Men With Erectile Dysfunction .

Brief Summary

To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Erectile Dysfunction

Intervention ^ICMJE

Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 10 mg. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks
Drug: Placebo
Placebo. After a 4 week run-in period, subjects were randomized in order to enroll 3 times more subjects in the vardenafil group than in the placebo group. The duration of the active treatment phase was 12 weeks

Study Arm (s)

Experimental: Arm 1
Intervention: Drug: Levitra (Vardenafil, BAY38-9456)
Placebo Comparator: Arm 2
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

193

Completion Date

February 2004

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Men 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months
having at least a 50% failure rate of sexual intercourse attempts during the run-in phase

Exclusion Criteria:

Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded.
Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded.
Subjects could not be on androgens/anti-androgens or alpha blockers.

Gender

Male

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT00661115

Other Study ID Numbers ^ICMJE

10695

Has Data Monitoring Committee

Yes

Responsible Party

Therapeutic Area Head, Bayer HealthCare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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