Study the Safety and Effectiveness of Tadalafil in Men With Diabetes Who Have Problems Getting and Keeping an Erection

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

Study to evaluate the safety and effectiveness of 2.5 mg and 5 mg tadalafil when taken by men with diabetes mellitus who have problems getting and maintaining an erection.

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

Details

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

Criteria

Inclusion Criteria:

• History of erectile dysfunction for at least 3 months.

• Currently have diabetes mellitus of at least 3 months duration.

• Agree to not use any other ED treatment during the study.

• Anticipate the same female sexual partner for the study.

• Must be willing to make the required number of sexual attempts.

Exclusion Criteria:

• History of other primary sexual disorder

• Treatment with nitrates or potent CYP3A4 inhibitors

• Have a penile implant or clinically significant penile deformity

• History of certain heart problems

• Have kidney or liver problems