A New Sildenafil Oral Film in Patients With Erectile Dysfunction (NCT05490680) | Clinical Trial Compass
CompletedPhase 3
A New Sildenafil Oral Film in Patients With Erectile Dysfunction
United States488 participantsStarted 2024-01-26
Plain-language summary
This is a Phase III, prospective, interventional, multi-center, randomized, double-blind, flexible-dose, placebo-controlled, parallel group clinical study required by FDA to demonstrate the efficacy and safety of Sildenafil oral film 25 mg, 50 mg, 75 mg and 100 mg as compared to placebo in approximately 488 men clinically diagnosed with erectile dysfunction (ED).
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:
* Heterosexual male subjects aged ≥18 years;
* Confirmed clinical diagnosis of ED for at least 6 months;
* Involved in a continuous sexual relationship with their partner for at least 3 months.
* Able and willing to provide voluntary written informed consent
Exclusion Criteria:
* Currently suffering from any oromucosal condition or recent oral surgery that could interfere with the study drug;
* Any significant cardiovascular abnormality;
* Patients ≥ 65 years with any degree of hepatic impairment or severe renal impairment or any significant pulmonary, gastrointestinal, hematological, endocrinal, metabolic or neurological disorder;
* Patients \< 65 years with severe hepatic impairment;
* Any presence of chronic indwelling urethral catheterization or penile anatomical abnormalities that would significantly impair EF;
* Any history of Peyronie's disease; or who have conditions which may predispose them to priapism;
* Any history or comorbidity of hypoactive sexual desire disorder, premature ejaculation or other ejaculatory disorders or radical prostatectomy;
* Any history of severe/uncontrolled diabetes or radical prostatectomy or spinal cord injury
* Hypersensitivity to Sildenafil or to any of the excipients of the oral film, or idiosyncratic reactions to other PDE5 inhibitors;
* Any history of migraine;
* Any history of complete unresponsiveness to PDE5 inhibitor treatment or significant side-effects with PDE5 inhibitor;
* Subjects with or with history …
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
Safety of Sildenafil doses versus placebo
Timeframe: 12 weeks of treatment
2
Efficacy of Sildenafil doses versus placebo - IIEF-EF
Timeframe: Baseline to the end of the 12-week treatment period
3
Efficacy of Sildenafil doses versus placebo - SEP Question 2
Timeframe: Between the 4-week pre-treatment period and the end of the 12-week treatment period
4
Efficacy of Sildenafil doses versus placebo - SEP Question 3
Timeframe: Between the 4-week pre-treatment period and the end of the 12-week treatment period