Erectile DysfunctionPhase 3NCT05490680
A New Sildenafil Oral Film in Patients With Erectile Dysfunction
A Phase 3 study testing Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg in people with Erectile Dysfunction, run by IBSA Institut Biochimique SA at 18 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 488 participants
- Where
- 18 sitesUnited States
- Study dates
- 26 Jan 2024to 9 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
G & L Research LLC.
Foley, Alabama, 36535
Innovation Medical Group LLC (Endo Care of South Florida)
Fort Lauderdale, Florida, 33316
AccuMed Research Associates
Garden City, New York, 11530
Medical Affiliated Research Center
Huntsville, Alabama, 35801
Alliance for Multispeciaty Research, LLC
Knoxville, Tennessee, 37909
Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, 89119
Arkansas Urology Research Center
Little Rock, Arkansas, 72211
Urology Group of Southern California
Los Angeles, California, 90017
Clintex Research Group
Miami, Florida, 33135
Coral Research Clinic
Miami, Florida, 33186
Tri Valley Urology Medical Group
Murrieta, California, 92562
Harmony Clinical Research
North Miami Beach, Florida, 33162
Innovation Clinical Trials: Medical Reseach Center
Palmetto Bay, Florida, 33157
Virginia Urology
Richmond, Virginia, 23235
Rochester Clinical Research, Inc
Rochester, New York, 14609
Mt. Olympus Medical Research Group, LLC
Sugar Land, Texas, 77479
Precision Clinical Research, LLC
Sunrise, Florida, 33351
Tranquil Clinical and Research Consulting Services, LLC
Webster, Texas, 77598
About this study
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)
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).
Read the 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.
- Conditions
- Erectile Dysfunction
- Being tested
- Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg, Placebo
- Keywords
- ED
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mgDrug
Also called Sildenafil Orodispersible Film
Sildenafil Oral Film containing 25 mg, 50 mg, 75 mg or 100 mg sildenafil as citrate, flexible-dose
PlaceboDrug
Also called Placebo-controlled
Placebo Oral Film
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo oral film, on-demand use once per day, at maximum 60 films during a 12-week period Receives: 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 Receives: Drug: Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: 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
Measured: 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
Measured: 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
Measured: 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
The incidence of TEAEs of Special Interest of headache
Measured: Over 12 weeks of treatment as compared to placebo
Safety TEAE of special interest - dizziness
The incidence of TEAEs of Special Interest of dizziness
Measured: Over 12 weeks of treatment as compared to placebo
Safety TEAE of vasomotor drug effects
The incidence of TEAEs that may be suggestive of vasomotor drug effects and the proportion of subjects with at least one of these TEAEs
Measured: Over 12 weeks of treatment as compared to placebo;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start26 Jan 2024
- Primary completion9 Dec 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitchell D. Efros, MD, Principal investigator, Accumed Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490680
- Sponsor's protocol ID
- 20US-SDF15
- Status last verified
- Oct 2025
- First submitted
- 4 Aug 2022
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05490680
- Acronym / sponsor ID
- 20US-SDF15
- Conditions
- Erectile Dysfunction
- Keywords
- ED
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral film, on-demand use once per day, at maximum 60 films during a 12-week period |
| Sildenafil | Experimental | Drug: Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mgSildenafil 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mgAlso: Sildenafil Orodispersible FilmSildenafil Oral Film containing 25 mg, 50 mg, 75 mg or 100 mg sildenafil as citrate, flexible-dose | Drug | Sildenafil |
| PlaceboAlso: Placebo-controlledPlacebo Oral Film | Drug | Placebo |
Primary outcome
Safety of Sildenafil doses versus placebo
Time frame: 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")
Efficacy of Sildenafil doses versus placebo - IIEF-EF
Time frame: 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
Efficacy of Sildenafil doses versus placebo - SEP Question 2
Time frame: 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 - SEP Question 3
Time frame: 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
3 secondary outcomes
Safety TEAE of special interest - headache
Time frame: Over 12 weeks of treatment as compared to placebo
Safety TEAE of special interest - dizziness
Time frame: Over 12 weeks of treatment as compared to placebo
Safety TEAE of vasomotor drug effects
Time frame: Over 12 weeks of treatment as compared to placebo;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell D. Efros, MD principal investigator
Accumed Research Associates
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil Oral Film 25 mg, 50 mg, 75 mg or 100 mg in people with Erectile Dysfunction, run by IBSA Institut Biochimique SA at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Sildenafil doses versus placebo (time frame: 12 weeks of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.