A Study of Visual Effects of Erectile Dysfunction Medications Dosed Daily for Six Months (NCT00333281) | Clinical Trial Compass
CompletedPhase 4
A Study of Visual Effects of Erectile Dysfunction Medications Dosed Daily for Six Months
United States198 participantsStarted 2005-06
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the effects on vision of six months of daily dosing of 5 mg tadalafil or 50 mg sildenafil compared with placebo.
Who can participate
Age range
30 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy male subjects or males with mild erectile dysfunction (ED).
* Between the ages of 30 and 65 years, inclusive.
Exclusion Criteria:
* Phosphodiesterase type 5 (PDE5) inhibitor therapy (tadalafil, sildenafil, or vardenafil) within 6 weeks of the start of the study.
* Diagnosis of diabetes mellitus.
* Any chronic illness or medication that is a risk factor for eye disease or any medication that causes retinal toxicity or affects visual function.
* Certain chronic medical conditions including unstable angina pectoris, severe renal \[kidney\] insufficiency, clinically significant hepatobiliary \[liver, bile duct\] disease, cancer, and AIDS/HIV.
* A history of clinically significant chronic ophthalmologic disease or any significant visual abnormality identified at the start of the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in dark-adapted bright flash b-wave amplitude on electroretinography (ERG) testing at baseline, 3 & 6 months on drug, and 4-6 weeks after discontinuation of drug.