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Completed

NCT Number: NCT00909233

LEVITRA® 20mg Special Drug Use Investigation (Long-term)

This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.

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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–64 year

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.

Treatment and study plan

Vardenafil, (Levitra, BAY38-9456)

Drug

Patients under daily life treatment receiving Levitra according to local drug information.

Primary outcomes

  1. Efficacy of patients with LEVITRA treatment

    Time frame: After 6 months

Secondary outcomes

  1. LEVITRA treatment improved the patient's erection

    Time frame: After 6 months

  2. LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse

    Time frame: After 6 months

  3. Reporting a second successful intercourse within 24 hours of dosing

    Time frame: After 6 months

  4. Patients prefer LEVITRA over last Erectile Dysfunction treatment

    Time frame: After 6 months

  5. Tolerability of patients with LEVITRA treatment

    Time frame: After 6 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
May 27, 2009
Registry last updated
Dec 15, 2014

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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