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

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ClinicalTrials.gov Identifier: NCT00422578
Recruitment Status : Completed
First Posted : January 17, 2007
Last Update Posted : October 25, 2007
ICOS Corporation
Information provided by:
Eli Lilly and Company

January 16, 2007
January 17, 2007
October 25, 2007
October 2004
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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.
Same as current
Complete list of historical versions of study NCT00422578 on ClinicalTrials.gov Archive Site
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.
Same as current
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Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction
Effect of Tadalafil on the Quality of Life and Sexual Life in Erectile Dysfunction (ED) Patients Previously Treated With Other Oral ED Therapy
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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Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Impotence
  • Erectile Dysfunction
Drug: tadalafil
Other Names:
  • LY450190
  • Cialis
  • IC351
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2005
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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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Eli Lilly and Company
ICOS Corporation
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP