check_circleStudy Completed

Erectile Dysfunction

Efficacy and safety of vardenafil in men with erectile dysfunction

Trial purpose

To find out more information on how effective and safe vardenafil is at treating impotence in men living in Russia.

Key Participants Requirements

Sex

Male

Age

18 Years
  • - 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.
    - Heterosexual relationship
    - Age range: 18 years and older
    - Documented written Informed Consent
    - 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?".

  • - 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) that in the opinion of the Investigator would significantly impair erectile function
    - Primary hypoactive sexual desire
    - Spinal cord injury
    - History of surgical prostatectomy (excluding TURP).
    - Retinitis pigmentosa
    - History of positive test for Hepatitis B surface antigen (HBsAg) or Hepatitis C.
    - History of positive test for HIV.9. Severe chronic or acute liver disease, history of moderate or severe hepatic impairment.
    - Clinically significant chronic hematological disease, which may lead to priapism such as sickle cell anemia and leukemia.
    - Bleeding disorder.
    - Significant active peptic ulceration.
    - 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).
    - 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)
    - NYHA Class III and IV heart failure
    - Symptomatic postural hypotension within 6 months of visit 1.
    - History of malignancy within the past 5 years (other than squamous or basal cell skin cancer).
    Concomitant Medication:
     -- Subjects who are taking nitrates or nitric oxide donors.
     -- Subjects who are taking anti-androgens
     -- Subjects who are taking androgens.
     -- Subjects who take anticoagulants, except for antiplatelet agents.
     -- 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.
     -- 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.
     -- Subjects who are taking alpha-blockers.
    Abnormal Laboratory Values:
     -- 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
     -- Subjects with a serum creatinine >3.0 mg/dl
     -- Elevation of AST and/or ALT >3X the ULN.
     -- Diabetic subjects with an HbA1c >12%.

Trial summary

Enrollment Goal
130
Trial Dates
August 2003 - March 2004
Phase
Phase 3
Could I Receive a placebo
No
Products
Levitra (Vardenafil, BAY38-9456)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Municipal Clinical Hospital N50Moscow, 127206, Russia
Completed
Russian State Medical University of RoszdravMoscow, 117997, Russia
Completed
Research Institute of UrologyMoscow, 105425, Russia
Completed
Russian University of Peoples' FriendshipMoscow, 117198, Russia
Completed
Central Hospital of Railway MinistryMoscow, 123367, Russia
Completed
Research Centre of X-ray and RadiologyMoscow, 117837, Russia
Terminated
St Petersburg Military Medical AcademySt Petersburg, 198013, Russia
Completed
Russian Med Academy of Post Graduate EducationMoscow, 125101, Russia

Primary Outcome

  • Erectile Function (EF) domain score
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Erectile Function (EF) domain score
    date_rangeTime Frame:
    Week 4, 8 and 12 Last Observation Carried Forward (LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • Change from baseline of Erectile Function domain score
    date_rangeTime Frame:
    Week 4, 8 and 12 Last Observation Carried Forward (LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • IIEF domain scores
    date_rangeTime Frame:
    Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • Patient Diary Questions
    date_rangeTime Frame:
    Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • Global Assessment Question (GAQ)
    date_rangeTime Frame:
    Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF)
    enhanced_encryption
    Safety Issue:
    no
  • Premature termination, adverse events, laboratory abnormalities and concomitant medication usage
    date_rangeTime Frame:
    Week 4, 8 and 12
    enhanced_encryption
    Safety Issue:
    yes
  • Measurements and changes from baseline in vital signs, ECG cardiac cycle measurements and ECG heart rate
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    yes
  • Haematology, Clinical Chemistry, Urinalysis
    date_rangeTime Frame:
    Week 12
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1