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).
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Goiânia 74110-020, Brazil
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sao Jose Rio Preto 15090-000, Brazil
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sao Paulo 04044-060, Brazil
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Milan 20132, Italy
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Malaga 29007, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sevilla 41013, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Vigo 36211, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., London NW8 9NH, United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Huntsville, Alabama 35801, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Newport Beach, California 92660, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Middlebury, Connecticut 06762, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Durham, County Durham DH1 2QW, United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Plymouth, Devonshire PL6 8BX, United Kingdom
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Adelaide, South Australia 5000, Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lichfield, Staffordshire WS14 9JL, United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Knoxville, Tennessee 37920, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., San Antonio, Texas 78229, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Malvern, Victoria 3144, Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Federal Way, Washington 98003, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Leeds, West Yorkshire LS9 7TF, United Kingdom
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Nedlands, Western Australia 6009, Australia