Effect of Tadalafil Once a Day in Men With Erectile Dysfunction

A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Assess the Efficacy and Safety of Tadalafil (LY450190) Once a Day in Subjects With Erectile Dysfunction Who Are Naïve to PDE5 Inhibitors

The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.

Inclusion Criteria:

• You are male and aged at least 18 years.
• Have a history of erectile dysfunction (ED)(defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration.
• Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study
• You agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication
• Your entry laboratory test results and medical tests meet study requirements
• You agree to use the study drug only as instructed by your study doctor and staff and to return any unused study drug and containers at the end of the study or as otherwise instructed by the study doctor.
• If currently using cholesterol lowering medications (for example: statins) or medications to lower blood pressure (example: angiotensin-converting enzyme (ACE) inhibitors or calcium channel blocker medications), you need to be on a stable dose and you and your study doctor do not expect any dose change during the study.

Exclusion Criteria:

• You have received previous or current treatment with tadalafil or any other PDE5 inhibitor.
• Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g. Avodart®).
• You have had significant heart disease as determined by your doctor in charge of this study or a member of the doctor's staff.
• Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months.
• Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.