Clinical trial NCT05490680: A New Sildenafil Oral Film in Patients With Erectile Dysfunction
Official title: A Multi-center, Prospective, Randomized, Double-blind, Flexible-dose, Placebo-controlled, Parallel Group Clinical Trial of Sildenafil Oral Film 25 mg, 50 mg, 75 mg and 100 mg for the Treatment of Erectile Dysfunction (ED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: ED
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 488
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 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

Primary outcomes:
measure: Safety of Sildenafil doses versus placebo
timeFrame: 12 weeks of treatment
measure: Efficacy of Sildenafil doses versus placebo - IIEF-EF
timeFrame: Baseline to the end of the 12-week treatment period
measure: 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
measure: 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
Secondary outcomes:
measure: Safety TEAE of special interest - headache
timeFrame: Over 12 weeks of treatment as compared to placebo
measure: Safety TEAE of special interest - dizziness
timeFrame: Over 12 weeks of treatment as compared to placebo
measure: Safety TEAE of vasomotor drug effects
timeFrame: Over 12 weeks of treatment as compared to placebo;
Other outcomes:
measure: Exploratory efficacy of Sildenafil oral film compared to placebo - attempts
timeFrame: Up to 12 weeks of treatment
measure: Exploratory efficacy of Sildenafil oral film compared to placebo - overall treatment satisfaction
timeFrame: Up to 12 weeks of treatment
measure: Exploratory efficacy of Sildenafil oral film compared to placebo - GAQ
timeFrame: Up to 12 weeks of treatment
measure: Exploratory efficacy of Sildenafil oral film compared to placebo - drug product palatability
timeFrame: Up to 12 weeks of treatment
Locations:
city: Foley
country: United States
facility: G & L Research LLC.
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Urology Research Center
state: Arkansas
city: Los Angeles
country: United States
facility: Urology Group of Southern California
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology Medical Group
state: California
city: Fort Lauderdale
country: United States
facility: Innovation Medical Group LLC (Endo Care of South Florida)
state: Florida
city: Miami
country: United States
facility: Clintex Research Group
state: Florida
city: Miami
country: United States
facility: Coral Research Clinic
state: Florida
city: North Miami Beach
country: United States
facility: Harmony Clinical Research
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Clinical Trials: Medical Reseach Center
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research, LLC
state: Florida
city: Las Vegas
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Nevada
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Knoxville
country: United States
facility: Alliance for Multispeciaty Research, LLC
state: Tennessee
city: Sugar Land
country: United States
facility: Mt. Olympus Medical Research Group, LLC
state: Texas
city: Webster
country: United States
facility: Tranquil Clinical and Research Consulting Services, LLC
state: Texas
city: Richmond
country: United States
facility: Virginia Urology
state: Virginia
Study officials:
affiliation: Accumed Research Associates
name: Mitchell D. Efros, MD
role: PRINCIPAL_INVESTIGATOR
References: