Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction

This study has been completed.
Sponsor:
Collaborator:
Onyx Pharmaceuticals
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00657644
First received: April 8, 2008
Last updated: October 9, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Erectile Dysfunction
Drug: Levitra (Vardenafil, BAY38-9456)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Erectile Function (EF) domain score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Erectile Function (EF) domain score [ Time Frame: Week 4, 8 and 12 Last Observation Carried Forward (LOCF) ] [ Designated as safety issue: No ]
  • Change from baseline of Erectile Function domain score [ Time Frame: Week 4, 8 and 12 Last Observation Carried Forward (LOCF) ] [ Designated as safety issue: No ]
  • IIEF domain scores [ Time Frame: Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF) ] [ Designated as safety issue: No ]
  • Patient Diary Questions [ Time Frame: Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF) ] [ Designated as safety issue: No ]
  • Global Assessment Question (GAQ) [ Time Frame: Week 4, 8, 12 and 12 Last Observation Carried Forward (LOCF) ] [ Designated as safety issue: No ]
  • Premature termination, adverse events, laboratory abnormalities and concomitant medication usage [ Time Frame: Week 4, 8 and 12 ] [ Designated as safety issue: Yes ]
  • Measurements and changes from baseline in vital signs, ECG cardiac cycle measurements and ECG heart rate [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Haematology, Clinical Chemistry, Urinalysis [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: August 2003
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
4 weeks treatment with 10 mg vardenafil followed by a flexible titration phase for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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?".

Exclusion Criteria:

  • 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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657644

Locations
Russian Federation
Moscow, Russian Federation, 127206
Moscow, Russian Federation, 117997
Moscow, Russian Federation, 105425
Moscow, Russian Federation, 117837
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 117198
Moscow, Russian Federation, 123367
St Petersburg, Russian Federation, 198013
Sponsors and Collaborators
Bayer
Onyx Pharmaceuticals
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00657644     History of Changes
Other Study ID Numbers: 11182
Study First Received: April 8, 2008
Last Updated: October 9, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Bayer:
Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 19, 2014