Erectile Dysfunction
Conditions
Keywords
Erectile Dysfunction
Brief summary
Study to investigate the efficacy and safety of vardenafil flexible dose versus placebo in males with erectile dysfunction, and their female partners' sexual quality of life.
Interventions
DRUGLevitra (Vardenafil, BAY38-9456)
BAY 38-9456 (Vardenafil) will be supplied as 5 mg tablets, 10 mg tablets, and 20 mg tablets.
DRUGPlacebo
Identical placebo tablets will be matched for each vardenafil dosage and will be indistinguishable from active treatment
Sponsors
GlaxoSmithKline
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males who have had ED for at least six months according to the National Institutes of Health (NIH) Consensus Conference December 7-9, 1992 (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance). * Stable, heterosexual relationship for more than 6 months. * Males 18 years, and older. * Written informed consent obtained. * The subject and his female partner must make at least four attempts at sexual intercourse on four separate days during the untreated baseline period (according to the answer to the following question in the Patient Diary: Was sexual activity initiated with the intention of intercourse?). * At least 50% of attempts at sexual intercourse during the untreated baseline period must be unsuccessful, according to the following questions from the subject diary (at least one question should be answered No): Were you able to achieve at least some erection (some enlargement of the penis)?; Were you able to insert your penis in your partner's vagina?; Did your erection last long enough for you to have successful intercourse?.
Exclusion criteria
A) Previous or current medical conditions: * Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the Investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study. * Presence of penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease) which, in the Investigator's opinion, would significantly impair erectile function. * Primary hypoactive sexual desire. * Spinal cord injury. * History of surgical prostatectomy (excluding TURP). * Retinitis pigmentosa. * Unstable angina pectoris. * History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months. * Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate ≥ 100 bpm). * Severe chronic or acute liver disease, history of moderate or severe hepatic impairment. * Clinically significant chronic haematological disease which may lead to priapism such as sickle cell anemia and leukemia. * Bleeding disorder. * Significant active peptic ulcer disease. * Resting hypotension (a resting systolic blood pressure of \< 90 mm Hg) or hypertension (a resting systolic blood pressure \> 170 mm Hg or a resting diastolic blood pressure \> 110 mm Hg). * History of malignancy within the past 5 years (other than squamous or basal cell skin cancer). * NYHA Class III and IV heart failure. * History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C. * Symptomatic postural hypotension within 6 months of visit 1. B) Concomitant medication: * Subjects who are taking nitrates or nitric oxide donors. * Subjects who take anticoagulants, except for antiplatelet agents. * Subjects who are taking androgens. * Subjects who are taking anti-androgens. * Subjects who are taking the following inhibitors of cytochrome P450 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin. * Subjects who have received any investigational drug (including placebo) within 30 days of Visit 1. * Use of any treatment for ED within 7 days of visit 1 or during the study, including oral medications, vacuum devices, constrictive devices, injections or urethral suppositories. * Subjects who are taking alpha blockers C) Abnormal laboratory values: * Subjects who have a serum total testosterone level more than 25% below the age-adjusted lower limit of normal according to the range of the testing laboratory. * Subjects with a serum creatinine \> 3.0 mg/dl. * Elevation of AST and/or ALT \> 3 times the upper limit of normal. * Diabetic subjects with an HbA1c\>12%. D) Other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary measures of efficacy in this study will be improved success of erection maintenance in men with ED and improvement in female partner's sexual quality of life. | Weeks 0 -12 |
Secondary
| Measure | Time frame |
|---|---|
| Additional Patient Diary questions at 4 weeks, 8 weeks, 12 weeks, LOCF, and over entire treatment period compared to placebo. Per-subject success rates will be calculated as the number of successes divided by the number of sexual attempts with a resp | Weeks 4, 8 and 12 |
| Global assessment question (GAQ) at weeks 4 and 12 of treatment compared to placebo | Weeks 4 and 12 |
| Global confidence question (GCQ) at 12 weeks of treatment compared to placebo. | Week 12 |
| SEP3 at weeks 4 and 12 of treatment compared to placebo. | Weeks 4 and 12 |
| Scores from the Treatment Satisfaction Scale (TSS) -- Subject Active Medication module at week 12 and LOCF of treatment compared to placebo. The TSS is a self-report measure of subject and partner's satisfaction with various aspects of erectile function | Week 12 |
| Scores from the mSLQQ-QOL at week 12 and LOCF of treatment compared to placebo | Week 12 |
| Percentage of subjects achieving back to normal rates of erectile functioning (IIEF-EF > 25) at week 12 of treatment compared to placebo. | Week 12 |
| The score for the IIEF questionnaire EF domain (IIEF-EF) at weeks 4, 12, and LOCF of treatment compared to placebo | Weeks 4 and 12 |
Countries
Canada, United States
Outcome results
None listed