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

Condition(s) targeted: Erectile Dysfunction

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

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

Study design: Cohort, Prospective

Primary outcome: Physician's assessment of safety (incidence of adverse events)

Secondary outcome:

Severity of ED symptoms

General quality of partnership as assessed by patient

General quality of partnership as assessed by partner

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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.

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Many Locations, China; Completed

Many Locations, Croatia; Completed

Many Locations, France; Recruiting

Many Locations, Germany; Active, not recruiting

Many Locations, Hungary; Recruiting

Many Locations, Indonesia; Recruiting

Many Locations, Korea, Republic of; Recruiting

Many Locations, Malaysia; Recruiting

Many Locations, Poland; Not yet recruiting

Many Locations, Saudi Arabia; Recruiting

Many Locations, Singapore; Recruiting

Many Locations, South Africa; Not yet recruiting

Many Locations, Spain; Recruiting

Many Locations, Sweden; Recruiting

Many Locations, Thailand; Not yet recruiting

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Starting date: April 2007
Ending date: December 2009
Last updated: October 9, 2009