A New Sildenafil Oral Film in Patients With Erectile Dysfunction
- Conditions
- Erectile Dysfunction
- Registration Number
- NCT05490680
- Lead Sponsor
- IBSA Institut Biochimique SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Male
- Target Recruitment
- 488
Inclusion Criteria:<br><br> - Heterosexual male subjects aged =18 years;<br><br> - Confirmed clinical diagnosis of ED for at least 6 months;<br><br> - Involved in a continuous sexual relationship with their partner for at least 3<br> months.<br><br> - Able and willing to provide voluntary written informed consent<br><br>Exclusion Criteria:<br><br> - Currently suffering from any oromucosal condition or recent oral surgery that could<br> interfere with the study drug;<br><br> - Any significant cardiovascular abnormality;<br><br> - Patients = 65 years with any degree of hepatic impairment or severe renal impairment<br> or any significant pulmonary, gastrointestinal, hematological, endocrinal, metabolic<br> or neurological disorder;<br><br> - Patients < 65 years with severe hepatic impairment;<br><br> - Any presence of chronic indwelling urethral catheterization or penile anatomical<br> abnormalities that would significantly impair EF;<br><br> - Any history of Peyronie's disease; or who have conditions which may predispose them<br> to priapism;<br><br> - Any history or comorbidity of hypoactive sexual desire disorder, premature<br> ejaculation or other ejaculatory disorders or radical prostatectomy;<br><br> - Any history of severe/uncontrolled diabetes or radical prostatectomy or spinal cord<br> injury<br><br> - Hypersensitivity to Sildenafil or to any of the excipients of the oral film, or<br> idiosyncratic reactions to other PDE5 inhibitors;<br><br> - Any history of migraine;<br><br> - Any history of complete unresponsiveness to PDE5 inhibitor treatment or significant<br> side-effects with PDE5 inhibitor;<br><br> - Subjects with or with history of severe vision impairment, temporary visual<br> disturbances (blurred vision, increased light sensitivity and color change),<br> retinitis pigmentosa, Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) or<br> any optic neuropathy;<br><br> - Subjects taking a strong CYP3A4 inhibitor(s);<br><br> - During the course of the study, subjects are not allowed to take any prescription,<br> over-the-counter, herbal, or naturopathic products for male enhancement or the<br> treatment of ED;<br><br> - During the course of the study, subjects are not allowed to take any form of nitric<br> oxide donors such as organic nitrates or organic nitrites either regularly and/or<br> intermittently, and guanylate cyclase (GC) stimulators;<br><br> - Patients must be stable on therapy with Alpha-blockers or Amlodipine at inclusion<br> and already taking a PDE5 inhibitor without any safety concern prior to initiating<br> the study (i.e., no history of significant side-effects with co-administration of<br> PDE5 inhibitors);<br><br> - Subjects known to abuse alcohol or drugs that could interfere with the patient's<br> safety or study compliance<br><br> - Subjects who are illiterate or are unable to understand how to use eDiary and<br> complete the questionnaires
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of Sildenafil doses versus placebo;Efficacy of Sildenafil doses versus placebo - IIEF-EF;Efficacy of Sildenafil doses versus placebo - SEP Question 2;Efficacy of Sildenafil doses versus placebo - SEP Question 3
- Secondary Outcome Measures
Name Time Method Safety TEAE of special interest - headache;Safety TEAE of special interest - dizziness;Safety TEAE of vasomotor drug effects