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NCT Number: NCT00422578

Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction

Study is a clinical study assessing the effect of oral tadalafil 10mg or 20 mg on psychosocial aspects and quality of life of erectile dysfunction patients and to compare tadalafil with previous oral erectile dysfunction medication. Study period is 13 weeks. Study patients fill in quality of life questionnaires and treatment satisfaction questionnaires.

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Key information

Conditions

Impotence 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

Interventional

Phase

Phase 4

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tampere, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • have a history of erectile dysfunction (defined as a consistent change in the quality of erection that adversely affects the patient's satisfaction with sexual intercourse)of at least 3 months duration
  • have been using any oral prescription medication,but not tadalafil, for erectile dysfunction for a minimum period of 3 months before visit 1
  • have responded to previous erectile dysfunction medication as assessed by the investigator

Exclusion criteria

  • exhibit evidence of clinically significant hepatobiliary disease (including jaundice) at visit 1
  • cardiovascular exclusion criteria: history of chronic stable angina treated with nitrates, recent acute cardiovascular events or procedures (myocardial infarction, coronary interventions, stroke, etc.), history of other serious cardiovascular events (e.g. arrhythmias, sudden cardiac arrest, congestive heart failure, etc.), systolic blood pressure <90mmHg or diastolic blood pressure <50mmHg at screening
  • receiving treatment with cancer chemotherapy

Treatment and study plan

Tadalafil

Drug

Other names: LY450190, Cialis, IC351

Primary outcomes

  1. On-demand therapy with tadalafil, as measured by the spontaneity domain of the PAIRS questionnaire increases the possibility to spontaneous sexual activity in ED patients compared with any other previous oral ED treatment.

Secondary outcomes

  1. Estimate the level of quality of life (15D and LiSat-11)in treated ED patients in order to be able to compare it with existing data of the general population and patients suffering from other diseases and symptoms.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • ICOS Corporation

Registry information

Official study title

Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction (ED) Patients Previously Treated With Other Oral ED Therapy

Important dates

Study start
2004
Study completion
2005
First posted
Jan 17, 2007
Registry last updated
Oct 25, 2007

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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