A New Sildenafil Oral Film in Patients With Erectile Dysfunction

NCT05490680 | Completed Phase 3 FDA Drug

• 1 other identifier: 20US-SDF15
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 18

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).

Conditions

Erectile Dysfunction

Keywords

ED

Outcome Measures

Primary Outcomes (4)

• Safety of Sildenafil doses versus placebo

  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")

  12 weeks of treatment

• Efficacy of Sildenafil doses versus placebo - IIEF-EF

  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

  Baseline to the end of the 12-week treatment period

• Efficacy of Sildenafil doses versus placebo - SEP Question 2

  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

  Between the 4-week pre-treatment period and the end of the 12-week treatment period

• Efficacy of Sildenafil doses versus placebo - SEP Question 3

  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

  Between the 4-week pre-treatment period and the end of the 12-week treatment period

Secondary Outcomes (3)

• Safety TEAE of special interest - headache

  Over 12 weeks of treatment as compared to placebo

• Safety TEAE of special interest - dizziness

  Over 12 weeks of treatment as compared to placebo

• Safety TEAE of vasomotor drug effects

  Over 12 weeks of treatment as compared to placebo;

Other Outcomes (4)

• Exploratory efficacy of Sildenafil oral film compared to placebo - attempts

  Up to 12 weeks of treatment

• Exploratory efficacy of Sildenafil oral film compared to placebo - overall treatment satisfaction

  Up to 12 weeks of treatment

• Exploratory efficacy of Sildenafil oral film compared to placebo - GAQ

  Up to 12 weeks of treatment

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo oral film, on-demand use once per day, at maximum 60 films during a 12-week period

Drug: Placebo

Sildenafil

EXPERIMENTAL

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

Drug: Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg

Interventions

Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg DRUG

Sildenafil Oral Film containing 25 mg, 50 mg, 75 mg or 100 mg sildenafil as citrate, flexible-dose

Also known as: Sildenafil Orodispersible Film

Sildenafil

Placebo DRUG

Placebo Oral Film

Also known as: Placebo-controlled

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (18)

G & L Research LLC.

Foley, Alabama, 36535, United States

Location

Medical Affiliated Research Center

Huntsville, Alabama, 35801, United States

Location

Arkansas Urology Research Center

Little Rock, Arkansas, 72211, United States

Location

Urology Group of Southern California

Los Angeles, California, 90017, United States

Location

Tri Valley Urology Medical Group

Murrieta, California, 92562, United States

Location

Innovation Medical Group LLC (Endo Care of South Florida)

Fort Lauderdale, Florida, 33316, United States

Location

Clintex Research Group

Miami, Florida, 33135, United States

Location

Coral Research Clinic

Miami, Florida, 33186, United States

Location

Harmony Clinical Research

North Miami Beach, Florida, 33162, United States

Location

Innovation Clinical Trials: Medical Reseach Center

Palmetto Bay, Florida, 33157, United States

Location

Precision Clinical Research, LLC

Sunrise, Florida, 33351, United States

Location

Alliance for Multispecialty Research, LLC

Las Vegas, Nevada, 89119, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Rochester Clinical Research, Inc

Rochester, New York, 14609, United States

Location

Alliance for Multispeciaty Research, LLC

Knoxville, Tennessee, 37909, United States

Location

Mt. Olympus Medical Research Group, LLC

Sugar Land, Texas, 77479, United States

Location

Tranquil Clinical and Research Consulting Services, LLC

Webster, Texas, 77598, United States

Location

Virginia Urology

Richmond, Virginia, 23235, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Mitchell D. Efros, MD

  Accumed Research Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: January 26, 2024
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)