On Demand Versus Daily Sildenafil for Patients Undergoing Radical Prostatectomy (NCT01315262) | Clinical Trial Compass
UnknownPhase 3
On Demand Versus Daily Sildenafil for Patients Undergoing Radical Prostatectomy
Italy200 participantsStarted 2011-01
Plain-language summary
Viagra (Sildenafil citrate) is an orally active selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) which is used for the treatment of erectile dysfunction (ED). Objectives:
* To test the efficacy of Viagra 100mg on demand vs. Viagra 100mg daily (taken either at bedtime or 1 hour prior to sexual intercourse) in restoring erectile function following radical prostatectomy.
* To test the safety and tolerability of Viagra 100 mg on demand vs. Viagra 100 mg daily after radical prostatectomy.
Who can participate
Age range
18 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
. Subjects who have given written informed consent to participate in the study.
. Men aged 18-65 years old.
. Weight range 50-100 Kg.
. Subjects must be in a stable relationship with the same partner for at least 6 months and willing to attempt sexual intercourse.
. Normal pre-operative erectile function (defined as IIEF-EF ≥ 26) without the use of therapy or devices for the improvement of erections.
. Prostatic Specific Antigen (PSA) lower than 10 ng/ml.
. Clinical prostate cancer stage T1c or T2.
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
Proportion of patients with an Erectile Function domain score of International Index of Erectile Function ( IIEF) => 22 at the end of the wash-out period (44 wks after surgery)
. Subjects in whom sexual activity is inadvisable in the opinion of the investigator such as significant cardiovascular disease in the last 6 months; including cardiac failure, myocardial infarction, unstable angina, stroke or transient ischemic attack (TIA), symptomatic or clinically significant cardiac arrhythmias including atrial fibrillation.
. Subjects who have a medical history of major hematological, renal, vascular or hepatic abnormalities, those with psychological or social circumstances that would impair their ability to participate reliably in the study, or those who may increase the risk to themselves or others by participating in the study.
. Subjects who have a medical history of diabetes.
. Subjects who developed a postoperative complication, namely reoperation for hemorrhage, a documented urinary fistula or the indwelling of catheter for 3 or more weeks.
. Subjects treated with neo-adjuvant radiotherapy or hormonotherapy.
. Subjects who have received or are receiving any PDE5 inhibitors.
. Subjects with known hypersensitivity to Viagra or any component of the study medication.
. Subjects with resting sitting hypotension (BP \< 90/50 mmHg), hypertension (BP \> 170/110 mmHg) or orthostatic hypotension.