To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.
Phase 3
Completed
- Conditions
- Erectile Dysfunction
- Interventions
- Drug: Placebo
- Registration Number
- NCT00661115
- Lead Sponsor
- Bayer
- Brief Summary
To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 173
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 Placebo - Arm 1 Levitra (Vardenafil, BAY38-9456) -
- Primary Outcome Measures
Name Time Method 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 At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts.
- Secondary Outcome Measures
Name Time Method Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use. At Weeks 4, 8 and 12 (as observed and at LOCF) Success in penetration and maintenance as recorded in subject diaries At Weeks 4, 8 and 12 (as observed and at LOCF) Scores for questions 3 and 4 of the IIEF At Weeks 4, 8 and 12 (as observed and at LOCF) Other IIEF domain scores At Week 12 (observed and at LOCF) Global Assessment Question (GAQ) responses At Weeks 4, 8 and 12 (as observed and at LOCF)