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Phosphodiesterase type 5 (PDE5) inhibitor

Sildenafil Oral Film for Erectile Dysfunction

Phase 3
Waitlist Available
Led By Mitchell D. Efros, MD
Research Sponsored by IBSA Institut Biochimique SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Heterosexual male subjects aged ≥18 years;
Confirmed clinical diagnosis of ED for at least 6 months;
Must not have
Patients < 65 years with severe hepatic impairment
Currently suffering from any oromucosal condition or recent oral surgery that could interfere with the study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between the 4-week pre-treatment period and the end of the 12-week treatment period
Awards & highlights
Pivotal Trial

Summary

"This trial will test the effectiveness and safety of different doses of Sildenafil oral film compared to a placebo in around 488 men with erectile dysfunction. It is a large study required by the FDA to see

Who is the study for?
This trial is for heterosexual men over 18 years old who have been diagnosed with erectile dysfunction (ED) for at least six months and are in a stable sexual relationship for three or more months. Specific details on who cannot participate were not provided.
What is being tested?
The study is testing a new Sildenafil oral film, available in four different strengths (25 mg, 50 mg, 75 mg, and 100 mg), against a placebo to check its effectiveness and safety in treating ED. Men will be randomly assigned to receive either the drug or placebo.
What are the potential side effects?
While specific side effects are not listed here, common side effects of Sildenafil include headaches, flushing, indigestion, nasal congestion, dizziness, and visual disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a heterosexual man aged 18 or older.
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I have been diagnosed with erectile dysfunction for at least 6 months.
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I am a heterosexual man aged 18 or older.
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I have been diagnosed with erectile dysfunction for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 65 and have severe liver problems.
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I have a mouth condition or had recent oral surgery that may affect the study drug.
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I have a history of sexual desire disorders or have undergone radical prostatectomy.
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I have a history of Peyronie's disease or conditions that could lead to prolonged erections.
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I have severe vision problems or a history of specific eye conditions.
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I have not responded to or had significant side effects from PDE5 inhibitor treatment.
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I am not taking any nitric oxide donors or guanylate cyclase stimulators.
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I have a history of migraines.
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I am currently taking strong medication that affects liver enzymes.
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I have a history of severe diabetes, prostate surgery, or spinal injury.
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I will not take any 'male enhancement' or ED treatment products during the study.
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I have a serious heart condition.
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I am over 65 and have liver, kidney, lung, stomach, blood, hormone, metabolism, or nerve problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between the 4-week pre-treatment period and the end of the 12-week treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and between the 4-week pre-treatment period and the end of the 12-week treatment period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
+1 more
Secondary study objectives
Safety TEAE of special interest - dizziness
Headache
Safety TEAE of vasomotor drug effects
Other study objectives
Exploratory efficacy of Sildenafil oral film compared to placebo - GAQ
Exploratory efficacy of Sildenafil oral film compared to placebo - attempts
Exploratory efficacy of Sildenafil oral film compared to placebo - drug product palatability
+1 more

Side effects data

From 2013 Phase 3 trial • 41 Patients • NCT01347008
5%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sugar Pill
Sildenafil Citrate

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SildenafilExperimental Treatment1 Intervention
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
Group II: PlaceboPlacebo Group1 Intervention
Placebo oral film, on-demand use once per day, at maximum 60 films during a 12-week period

Find a Location

Who is running the clinical trial?

IBSA Institut Biochimique SALead Sponsor
38 Previous Clinical Trials
9,547 Total Patients Enrolled
Mitchell D. Efros, MDPrincipal InvestigatorAccumed Research Associates
Giuseppe MautoneStudy DirectorIBSA Head of R&D Scientific Affairs
1 Previous Clinical Trials
126 Total Patients Enrolled
~0 spots leftby Dec 2024
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