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:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT00836693
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00836693
Study Brief:
Protocol Section:
NCT00836693