Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT00734604
Eligibility 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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00734604
Study Brief:
Protocol Section:
NCT00734604