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Phosphodiesterase type 5 (PDE5) inhibitor

Sildenafil for Erectile Dysfunction

Phase 3
Recruiting
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;
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

Study 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.Check my eligibility
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.See study design
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
Select...
I am a heterosexual man aged 18 or older.
Select...
I have been diagnosed with erectile dysfunction for at least 6 months.
Select...
I am a heterosexual man aged 18 or older.
Select...
I have been diagnosed with erectile dysfunction for at least 6 months.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Safety TEAE of special interest - dizziness
Headache
Safety TEAE of vasomotor drug effects
Other outcome measures
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 2018 Phase 4 trial • 6 Patients • NCT01642407
50%
Bronchitis
50%
Nasopharyngitis
50%
Upper respiratory tract infection
33%
Headache
33%
Epistaxis
33%
Diarrhoea
33%
Gastroenteritis
17%
Vision blurred
17%
Eczema
17%
Rash
17%
Flushing
17%
Alanine aminotransferase increased
17%
Ammonia increased
17%
Aspartate aminotransferase increased
17%
Weight increased
17%
Dysmenorrhoea
17%
Erection increased
17%
Pulmonary arterial hypertension
17%
Rhinitis allergic
17%
Acne
17%
Dermatitis diaper
17%
Dry skin
17%
Visual acuity reduced transiently
17%
Colitis
17%
Molluscum contagiosum
17%
Streptococcal infection
17%
Blood urine present
17%
Myalgia
17%
Cardiac failure
17%
Conjunctivitis allergic
17%
Dental caries
17%
Vomiting
17%
Chest pain
17%
Feeling abnormal
17%
Influenza
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sildenafil

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
36 Previous Clinical Trials
9,469 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How numerous are the medical facilities conducting this study in Canada?

"Enrollment for this study is open at various esteemed institutions such as Precision Clinical Research, LLC in Sunrise, Florida; Medical Affiliated Research Center in Huntsville, Arkansas; and Arkansas Urology Research Center in Little Rock. Additionally, there are 19 other locations available for patient enrollment."

Answered by AI

Has the FDA given its approval for Sildenafil?

"According to our evaluation at Power, the safety rating for Sildenafil is 3 due to its Phase 3 trial status, indicating presence of efficacy data and multiple iterations of safety data."

Answered by AI

Are there any ongoing efforts to enroll patients in this clinical trial?

"Indeed, the details on clinicaltrials.gov indicate an ongoing recruitment drive for this research. The trial was first listed on January 26th, 2024 and updated most recently on February 2nd, 2024. It aims to enroll a total of 488 participants from nineteen distinct locations."

Answered by AI

What is the current number of individuals being recruited for participation in this research investigation?

"The study necessitates 488 eligible participants to meet the inclusion criteria. IBSA Institut Biochimique SA, the sponsor, will oversee operations at various sites such as Precision Clinical Research, LLC in Sunrise, Florida and Medical Affiliated Research Center in Huntsville, Arkansas."

Answered by AI

Who else is applying?

What site did they apply to?
Precision Clinical Research, LLC
Tri Valley Urology Medical Group
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Trying the new Rx.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A New Sildenafil Oral Film in Patients With Erectile Dysfunction
2024. "A New Sildenafil Oral Film in Patients With Erectile Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05490680.
All > Erectile Dysfunction > Viagra
~305 spots leftby Oct 2024
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