A Study in Patients With Erectile Dysfunction (NCT01122264) | Clinical Trial Compass
CompletedPhase 4
A Study in Patients With Erectile Dysfunction
France, Germany, Greece770 participantsStarted 2010-05
Plain-language summary
The purpose of this study is to investigate if treatment in erectile dysfunction with a long-acting drug (Tadalafil) taken once a day or taken as needed results in a longer treatment adherence and better long term outcomes (over 24 weeks), compared with a short-acting drug (Sildenafil Citrate) taken as needed.
Who can participate
Age range
18 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:
* History of Erectile Dysfunction (ED) of at least 3 months duration.
* Anticipate having the same adult female sexual partner during the study.
* Agree not to use any other treatment for ED and to participate in recording responses to questionnaires and other instruments used in this study.
Exclusion Criteria:
* Previous or current treatment with tadalafil or any other phosphodiesterase type 5 (PDE5) inhibitor.
* ED caused by other primary sexual disorders, history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection, or history of penile implant or clinically significant penile deformity.
* ED caused by untreated or inadequately treated endocrine disease.
* Current treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens.
* Severe renal or hepatic impairment, history of malignant hypertension.
* Presence or history of specific heart conditions.
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.