REPEAT - Real-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra Therapy

Erectile Dysfunction Clinical Trial

Official title:

REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00874679
• Other study ID #: 12805
• Secondary ID: REPEATLV06021294
• Status: Completed
• Phase: N/A
• First received: April 1, 2009
• Last updated: November 9, 2011
• Start date: March 2007
• Est. completion date: April 2010

Study information

• Verified date: November 2011
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesChina: Ethics CommitteeSpain: Ministry of HealthFrance: French Data Protection AuthorityCroatia: Agency for Medicinal Product and Medical DevicesCroatia: Ethics CommitteeHungary: National Institute of PharmacyIndonesia: National Agency of Drug and Food ControlSouth Korea: Institutional Review BoardMalaysia: Medical Research Ethics Committee (MREC)Malaysia: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSweden: Regional Ethical Review BoardSingapore: Domain Specific Review BoardsSingapore: Health Sciences AuthorityThailand: Ethical CommitteeSouth Africa: Human Research Ethics CommitteeSouth Africa: Department of HealthSouth Africa: Medicines Control CouncilSouth Africa: National Health Research Ethics Council
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7293
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Outpatients with diagnosis of erectile dysfunction, decision taken by the investigator to prescribe Vardenafil.

Exclusion Criteria:

• Exclusion criteria must be read in conjunction with the local product information. All contraindications listed in the local product information are applicable.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• Levitra (Vardenafil, BAY38-9456)
Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

China,  Croatia,  France,  Germany,  Hungary,  Indonesia,  Korea, Republic of,  Malaysia,  Poland,  Saudi Arabia,  Singapore,  South Africa,  Spain,  Sweden,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician's assessment of safety (incidence of adverse events)		During observation period	Yes
Secondary	Severity of ED symptoms		End of study	No
Secondary	General quality of partnership as assessed by patient		Initial visit and after 3, 6, 9 and 12 months	No
Secondary	General quality of partnership as assessed by partner		Initial visit and after 3, 6, 9 and 12 months	No

External Links

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