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Completed

NCT Number: NCT00874679

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

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.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levitra (Vardenafil, BAY38-9456)

Drug

Patients with diagnosis of erectile dysfunction who get vardenafil in routine treatment

Primary outcomes

  1. Physician's assessment of safety (incidence of adverse events)

    Time frame: During observation period

Secondary outcomes

  1. Severity of ED symptoms

    Time frame: End of study

  2. General quality of partnership as assessed by patient

    Time frame: Initial visit and after 3, 6, 9 and 12 months

  3. General quality of partnership as assessed by partner

    Time frame: Initial visit and after 3, 6, 9 and 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Apr 2, 2009
Registry last updated
Nov 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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