Official Title: “Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life”

To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

Intervention(s) in this Clinical Trial

• Drug: tadalafil
  • 5 mg tadalafil tablet taken by mouth once a day for 12 weeks
• Drug: Placebo
  • placebo tablet taken by mouth once a day for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Placebo
• Active Comparator: 2
  • 5 mg tadalafil

Primary Measures

• Change from baseline to endpoint in the IIEF Erectile Function domain score ( sum of questions 1-5 and 15) and percent of yes responses to questions 2 and 3 of SEP.
  • Time Frame: 12 weeks
    Safety Issue?: No
• To evaluate improvement of sexual quality of life as measured by the Sexual Quality of Life domain of the Sexual Life Quality Questionnaire
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• To evaluate tadalafil 5 mg once daily compared with placebo in improving intercourse satisfaction in the subject and his female study partner
  • Time Frame: 12 weeks
    Safety Issue?: No
• To evaluate tadalafil 5 mg once daily compared with placebo in improving sexual satisfaction in the subject and his female study partner
  • Time Frame: 12 weeks
    Safety Issue?: No
• To evaluate tadalafil 5 mg once daily compared with placebo in improving treatment satisfaction in the subject and his female study partner
  • Time Frame: 12 weeks
    Safety Issue?: No
• Assess safety by monitoring adverse events.
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Male
• History of ED for at least a 3 months duration
• Anticipate having the same female partner willing to participate throughout the study
• At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study
• Adequate partner sexual function as determined by a Female Sexual Function Index
• Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study

Exclusion Criteria:

• May not participate in the study if you have taken tadalafil previously.
• History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study.
• Have sexual partner not willing to complete the scales.
• Use of nitrates.

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 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00422734

Study ID Number: 9501

ClinicalTrials.gov Identifier: NCT00422734

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry