Erectile Dysfunction
Conditions
Keywords
Erectile dysfunction, Sexual Dysfunction
Brief summary
To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.
Interventions
DRUGLevitra (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
DRUGPlacebo
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
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
Countries
India
Outcome results
None listed