A Study for Patients With Erectile Dysfunction to Test Whether Tadalafil Taken Once a Day Can Better Improve Psychological Outcomes.

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).

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

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Citric Acid; Sildenafil Citrate; Tadalafil

Criteria

Inclusion Criteria:

• History of erectile dysfunction (ED).

• Have had satisfactory response to tadalafil, sildenafil citrate, or vardenafil HCl for a period of at least 6 months and expect frequent use (at least one dose per week, on average) when administered as needed.

• Have never used tadalafil 5 mg or 2.5 mg once a day therapy.

• Anticipate having the same adult female sexual partner willing to participate during the study.

• Agree to make at least four sexual intercourse attempts during the first four weeks of the study.

• Agree not to use any other treatment for ED (even herbal treatments) during the study.

• Agree to follow the directions given by the study doctor and staff about using the study drug.

Exclusion Criteria:

• Have any other primary sexual disorders present or penile deformity.

• Have history of radical prostatectomy or penile implant.

• Have problems with your kidneys, liver, or nervous system.

• Have uncontrolled diabetes, as measured by a blood test for haemoglobin A1C greater than a value of 11%.

• Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin).

• Have chest pain (called unstable angina or angina) that requires treatment.

• Have heart disease that causes symptoms after you exert yourself.

• Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).

• Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION).

• Have retinitis pigmentosa.

• Have history of human immunodeficiency virus (HIV).

• Have very high or very low blood pressure (your study doctor will discuss the limits with you).

• Have had a stroke or a significant injury to your brain or spinal cord within the last 6 months.

• Have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Lactose intolerance.

• Have a scheduled or planned surgery requiring anaesthesia during the course of the study.

• Have a scheduled cataract surgery during the curse of the study.