A New Sildenafil Oral Film in Patients With Erectile Dysfunction
- Conditions
- Erectile Dysfunction
- Interventions
- Registration Number
- NCT05490680
- Lead Sponsor
- IBSA Institut Biochimique SA
- Brief 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).
- Detailed Description
The study will consist of a Screening Visit (Visit 0) followed by a 4-week run-in period without treatment and by a Randomization Visit (Visit 1) for the subjects who were compliant in pre-treatment phase. After randomization, the subject will start a 12-week, double-blind, flexible-dose, treatment phase comprising 4 at Site Visits performed 2 weeks after starting the treatment (Visit 2), after additional 2 weeks (Visit 3) and every 4 weeks (Visits 4 and 5) until the End of Study.
The target population for this study is men with ED, including 30-35% of geriatric ED subjects. Subjects \< 65 years of age will be randomized to receive the Sildenafil/Placebo oral film at 50 mg dose. Subjects ≥ 65 years of age will be randomized to receive the Sildenafil/Placebo oral film at 25 mg dose. The study foresees a flexible-dose regimen and the starting dosage can be increased to 50 mg (for subjects ≥ 65 years of age), 75 mg or 100 mg dosage, or decreased.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 488
- 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
- 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 of severe vision impairment, temporary visual disturbances (blurred vision, increased light sensitivity and color change), retinitis pigmentosa, Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) or any optic neuropathy;
- Subjects taking a strong CYP3A4 inhibitor(s);
- During the course of the study, subjects are not allowed to take any prescription, over-the-counter, herbal, or naturopathic products for "male enhancement" or the treatment of ED;
- During the course of the study, subjects are not allowed to take any form of nitric oxide donors such as organic nitrates or organic nitrites either regularly and/or intermittently, and guanylate cyclase (GC) stimulators;
- Patients must be stable on therapy with Alpha-blockers or Amlodipine at inclusion and already taking a PDE5 inhibitor without any safety concern prior to initiating the study (i.e., no history of significant side-effects with co-administration of PDE5 inhibitors);
- Subjects known to abuse alcohol or drugs that could interfere with the patient's safety or study compliance
- Subjects who are illiterate or are unable to understand how to use eDiary and complete the questionnaires
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo oral film, on-demand use once per day, at maximum 60 films during a 12-week period Sildenafil Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg Sildenafil 25 mg, 50 mg, 75 mg or 100 mg oral film (flexible-dose), on-demand use once per day, at maximum 60 films during a 12-week period
- Primary Outcome Measures
Name Time Method Efficacy of Sildenafil doses versus placebo - SEP Question 3 Between the 4-week pre-treatment period and the end of the 12-week treatment period Efficacy of Sildenafil oral film versus placebo evaluated using co-primary efficacy endpoint from the change in percentage of "yes" responses to SEP Question 3
Efficacy of Sildenafil doses versus placebo - SEP Question 2 Between the 4-week pre-treatment period and the end of the 12-week treatment period Efficacy of Sildenafil oral film versus placebo evaluated using co-primary efficacy endpoint from the change in percentage of "yes" responses to Sexual Encounter Profile (SEP) Question 2
Efficacy of Sildenafil doses versus placebo - IIEF-EF Baseline to the end of the 12-week treatment period Efficacy of Sildenafil oral film versus placebo evaluated using co-primary efficacy endpoint from the change in Erectile Function (EF) domain of the International Index for Erectile Function (IIEF) questionnaire
Safety of Sildenafil doses versus placebo 12 weeks of treatment Safety of Sildenafil doses versus placebo, i.e., the proportion of subjects with at least one Treatment Emergent Adverse Events (TEAEs) of Special Interest ("Headache" or "Dizziness")
- Secondary Outcome Measures
Name Time Method Safety TEAE of special interest - dizziness Over 12 weeks of treatment as compared to placebo The incidence of TEAEs of Special Interest of dizziness
Safety TEAE of vasomotor drug effects Over 12 weeks of treatment as compared to placebo; The incidence of TEAEs that may be suggestive of vasomotor drug effects and the proportion of subjects with at least one of these TEAEs
Safety TEAE of special interest - headache Over 12 weeks of treatment as compared to placebo The incidence of TEAEs of Special Interest of headache
Trial Locations
- Locations (18)
Urology Group of Southern California
🇺🇸Los Angeles, California, United States
Clintex Research Group
🇺🇸Miami, Florida, United States
Coral Research Clinic
🇺🇸Miami, Florida, United States
Alliance for Multispecialty Research, LLC
🇺🇸Las Vegas, Nevada, United States
Arkansas Urology Research Center
🇺🇸Little Rock, Arkansas, United States
G & L Research LLC.
🇺🇸Foley, Alabama, United States
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Tri Valley Urology Medical Group
🇺🇸Murrieta, California, United States
Innovation Medical Group LLC (Endo Care of South Florida)
🇺🇸Fort Lauderdale, Florida, United States
Harmony Clinical Research
🇺🇸North Miami Beach, Florida, United States
Innovation Clinical Trials: Medical Reseach Center
🇺🇸Palmetto Bay, Florida, United States
Precision Clinical Research, LLC
🇺🇸Sunrise, Florida, United States
Alliance for Multispeciaty Research, LLC
🇺🇸Knoxville, Tennessee, United States
Rochester Clinical Research, Inc
🇺🇸Rochester, New York, United States
AccuMed Research Associates
🇺🇸Garden City, New York, United States
Mt. Olympus Medical Research Group, LLC
🇺🇸Sugar Land, Texas, United States
Tranquil Clinical and Research Consulting Services, LLC
🇺🇸Webster, Texas, United States
Virginia Urology
🇺🇸Richmond, Virginia, United States