Tadalafil Taken Daily Compared to Placebo on Improvement of Getting and Maintaining an Erection and Sexual Quality of Life

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: ICOS Corporation
• Treatments: Tadalafil

Criteria

Inclusion Criteria:

Male

• History of erectile dysfunction (ED) for at least 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.