Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction (NCT01698684) | Clinical Trial Compass
CompletedPhase 4
Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction
United States440 participantsStarted 2012-09
Plain-language summary
The objectives of this study are to examine the therapeutic effects of two doses of avanafil after dosing in men with erectile dysfunction
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:
* Males ≥ 18 years of age;
* Minimum 6 months of erectile dysfunction;
* In a monogamous, heterosexual relationship for at least 3 months;
* Agree to make at least 4 attempts at intercourse per month;
* Provide written informed consent;
* Agree not to use any other ED treatments for erectile dysfunction;
* Willing and able to comply with all study requirements.
Exclusion Criteria:
* Allergy or hypersensitivity to PDE5 inhibitors;
* History of dose-limiting AEs with a PDE5 inhibitor or discontinued use of a PDE5 inhibitor;
* Concomitant use of one or more of the following medications:
* Other prescription or OTC drugs known to interfere with metabolism by the CYP 3A4 enzyme;
* Dose of an alpha blocker that has not been stable for at least 14 days;
* Any nitrate;
* ED as a consequence of advanced neurologic disease, spinal cord injury,or radical prostatectomy;
* Myocardial infarction, stroke, life-threatening arrhythmia or coronary revascularization within the past 6 months;
* Unstable angina, angina with sexual intercourse, or congestive heart failure \> NYHA Class II;
* Poorly controlled type 1 or type 2 diabetes;
* Evidence of prostate cancer or previous radical prostatectomy;
* Untreated hypogonadism or total testosterone levels outside normal reference range;
* Abnormal laboratory value(s) judged to be clinically significant by the investigator;
* Positive urine drug screen;
* History of retinitis pigmentosa, nonarteritic anterior ischemic opt…
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
Per-subject Proportion of Sexual Attempts That Had an Erectogenic Effect Within Approximately 15 Minutes Following Dosing
Timeframe: Week 0 (Baseline) up to Week 8 (End of Study)