Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Intervention(s) in this Clinical Trial

• Drug: tadalafil

Primary Measures

• 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 Measures

• 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.

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00422578

Study ID Number: 9113

ClinicalTrials.gov Identifier: NCT00422578

Health Authority: Finland: Ministry of Social Affairs and Health

Lilly Clinical Trial Registry