Status:

COMPLETED

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

Lead Sponsor:

Eli Lilly and Company

Collaborating Sponsors:

ICOS Corporation

Conditions:

Impotence

Erectile Dysfunction

Eligibility:

MALE

18+ years

Phase:

PHASE4

Brief Summary

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 1 2004

Trial Type :

INTERVENTIONAL

End Date :

September 1 2005

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00422578

Start Date

October 1 2004

End Date

September 1 2005

Last Update

October 25 2007

Active Locations (1)

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1

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