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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00874679 |
The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. Furthermore, the data collection particularly focuses on the experience of the patient and his satisfaction with the treatment. Treatment naive patients as well as pre-treated patients will be included in the study.
The maximum observation period per patient is 12 months. Besides the physician's documentation, the patient should fill out a questionnaire at every visit. The questionnaires will be handed out and collected by the physician. Furthermore, an additional questionnaire for the patient's partner can be distributed at each visit in case the partner is willing to participate.
Condition | Intervention | Phase |
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Erectile Dysfunction |
Drug: Levitra (Vardenafil, BAY38-9456) |
Phase IV |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy |
n.a.
Estimated Enrollment: | 5000 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Group 1 |
Drug: Levitra (Vardenafil, BAY38-9456)
Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment
Inclusion Criteria:
Exclusion Criteria:
Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
China | |
Not yet recruiting | |
Many Locations, China | |
Croatia | |
Not yet recruiting | |
Many Locations, Croatia | |
France | |
Not yet recruiting | |
Many Locations, France | |
Germany | |
Recruiting | |
Many Locations, Germany | |
Hungary | |
Not yet recruiting | |
Many Locations, Hungary | |
Indonesia | |
Not yet recruiting | |
Many Locations, Indonesia | |
Korea, Republic of | |
Not yet recruiting | |
Many Locations, Korea, Republic of | |
Malaysia | |
Not yet recruiting | |
Many Locations, Malaysia | |
Poland | |
Not yet recruiting | |
Many Locations, Poland | |
Saudi Arabia | |
Not yet recruiting | |
Many Locations, Saudi Arabia | |
Singapore | |
Not yet recruiting | |
Many Locations, Singapore | |
South Africa | |
Not yet recruiting | |
Many Locations, South Africa | |
Spain | |
Not yet recruiting | |
Many Locations, Spain | |
Sweden | |
Not yet recruiting | |
Many Locations, Sweden | |
Thailand | |
Not yet recruiting | |
Many Locations, Thailand |
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | Bayer Healthcare AG ( Global Medical Affairs Therapeutic Area Head ) |
Study ID Numbers: | 12805, LV0602, 12842, 12942, 12975, 12976, 12977, 13047, 13048, 13067, 13093, 13112, 13208, 13416, 13417, 13600, 13930, 13931, 14328 |
Study First Received: | April 1, 2009 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00874679 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; China: Ethics Committee; Spain: Ministry of Health; France: French Data Protection Authority; Croatia: Agency for Medicinal Product and Medical Devices; Croatia: Ethics Committee; Hungary: National Institute of Pharmacy; Indonesia: National Agency of Drug and Food Control; South Korea: Institutional Review Board; Malaysia: Medical Research Ethics Committee (MREC); Malaysia: Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Sweden: Regional Ethical Review Board; Singapore: Domain Specific Review Boards; Singapore: Health Sciences Authority; Thailand: Ethical Committee; South Africa: Human Research Ethics Committee; South Africa: Department of Health; South Africa: Medicines Control Council; South Africa: National Health Research Ethics Council |
Sexual Dysfunctions, Psychological Phosphodiesterase Inhibitors Vardenafil Sexual Dysfunction, Physiological |
Mental Disorders Genital Diseases, Male Erectile Dysfunction |
Sexual Dysfunctions, Psychological Phosphodiesterase Inhibitors Vardenafil Sexual Dysfunction, Physiological Molecular Mechanisms of Pharmacological Action Mental Disorders |
Enzyme Inhibitors Genital Diseases, Male Sexual and Gender Disorders Erectile Dysfunction Pharmacologic Actions |