Back to resultsTo Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.
Primary Purpose
Erectile Dysfunction
Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Levitra (Vardenafil, BAY38-9456)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile dysfunction, Sexual Dysfunction
Eligibility Criteria
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.
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
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
Secondary Outcome Measures
Success in penetration and maintenance as recorded in subject diaries
Scores for questions 3 and 4 of the IIEF
Other IIEF domain scores
Global Assessment Question (GAQ) responses
Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00661115
Brief Title
To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.
Official Title
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 .
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction
Keywords
Erectile dysfunction, Sexual Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
173 (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. 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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Success in penetration and maintenance as recorded in subject diaries
Time Frame
At Weeks 4, 8 and 12 (as observed and at LOCF)
Title
Scores for questions 3 and 4 of the IIEF
Time Frame
At Weeks 4, 8 and 12 (as observed and at LOCF)
Title
Other IIEF domain scores
Time Frame
At Week 12 (observed and at LOCF)
Title
Global Assessment Question (GAQ) responses
Time Frame
At Weeks 4, 8 and 12 (as observed and at LOCF)
Title
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)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560010
Country
India
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
City
Belagum
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400007
Country
India
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400022
Country
India
City
Madurai
State/Province
Tamilnadu
ZIP/Postal Code
625107
Country
India
12. IPD Sharing Statement
Learn more about this trial
To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.
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