Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Erectile Dysfunction
Intervention: Levitra (Vardenafil, BAY38-9456) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
To find out more information on how effective and safe vardenafil is at treating impotence in
men living in Russia.
Clinical Details
Official title: Open-Label Multi-Centre Non Randomised Study of Efficacy and Safety of Vardenafil (BAY 38-9456; SB-782528) Administered in Flexible-Dose Regimen in Males With Erectile Dysfunction of Broad Aetiology.
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Erectile Function (EF) domain score
Secondary outcome: Erectile Function (EF) domain scoreChange from baseline of Erectile Function domain score IIEF domain scores Patient Diary Questions Global Assessment Question (GAQ) Premature termination, adverse events, laboratory abnormalities and concomitant medication usage Measurements and changes from baseline in vital signs, ECG cardiac cycle measurements and ECG heart rate Haematology, Clinical Chemistry, Urinalysis
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
Inclusion Criteria:
1. Males with ED according to the NIH definition (the inability to achieve or maintain
penile erection sufficient for satisfactory sexual performance) for at least 3
months.
2. Heterosexual relationship.
3. Age range: 18 years and older.
4. Documented written Informed Consent.
5. The subject must make at least four attempts at sexual intercourse (according to the
question in the subject diary "Was sexual activity initiated with the intention of
intercourse?") on four separate days during the untreated baseline period. At least
50% of attempts during this 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 partial erection (some enlargement of the penis)?", "Were
you able to insert your penis in your partner's vagina?" and "Did your erection last
long enough for you to have successful intercourse?".
Exclusion Criteria:
1. 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.
2. Presence of penile anatomical abnormalities (e. g. penile fibrosis or Peyronie's
disease) that in the opinion of the Investigator would significantly impair erectile
function.
3. Primary hypoactive sexual desire.
4. Spinal cord injury.
5. History of surgical prostatectomy (excluding TURP).
6. Retinitis pigmentosa.
7. History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C.
8. History of positive test for HIV.
9. Severe chronic or acute liver disease, history of moderate or severe hepatic
impairment.
10. Clinically significant chronic hematological disease, which may lead to priapism such
as sickle cell anemia and leukemia.
11. Bleeding disorder.
12. Significant active peptic ulceration.
13. Unstable angina pectoris.
14. History of myocardial infarction, stroke or life-threatening arrhythmia within the
prior 6 months.
15. Uncontrolled atrial fibrillation/flutter at screening (ventricular response rate > 100
bpm).
16. 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).
17. NYHA Class III and IV heart failure.
18. Symptomatic postural hypotension within 6 months of visit 1.
19. History of malignancy within the past 5 years (other than squamous or basal cell skin
cancer).
Concomitant Medication
1. Subjects who are taking nitrates or nitric oxide donors.
2. Subjects who are taking anti-androgens.
3. Subjects who are taking androgens.
4. Subjects who take anticoagulants, except for antiplatelet agents.
5. Subjects who have received any investigational drug (including placebo) within 30 days
of visit 1.
6. Use of any treatment for ED within the 7 days of visit 1 or during the study,
including oral medications, vacuum devices, constrictive devices, injections or
urethral suppositories.
7. Subjects who are taking the following potent inhibitors of cytochrome P- 450 3A4: HIV
protease inhibitors such as ritonavir or indinavir, the anti-mycotic agents
itraconazole and ketoconazole (topical forms are allowed) or erythromycin.
8. Subjects who are taking alpha-blockers. Abnormal Laboratory Values
1. Subjects who have a serum total testosterone level greater than 25% below the lower
limit of normal according to the range of the testing laboratory.
2. Subjects with a serum creatinine >3. 0 mg/dl. 3. Elevation of AST and/or ALT >3X the ULN.
4. Diabetic subjects with an HbA1c >12%.
Locations and Contacts
Moscow 105425, Russian Federation
Moscow 111020, Russian Federation
Moscow 127206, Russian Federation
Moscow 123367, Russian Federation
Moscow 117837, Russian Federation
Moscow 125101, Russian Federation
Moscow 117997, Russian Federation
Additional Information
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Starting date: August 2003
Ending date: March 2004
Last updated: April 11, 2008
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