A New Sildenafil Oral Film in Patients With Erectile Dysfunction

March 7, 2024 updated by: IBSA Institut Biochimique SA

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

488

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Foley, Alabama, United States, 36535
        • Recruiting
        • G & L Research LLC.
        • Contact:
          • Lindsay U. Russell, CCRC
          • Phone Number: 251-943-2980
        • Principal Investigator:
          • Nidal Morrar, MD
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Medical Affiliated Research Center
        • Contact:
          • Jaime Akridge, LPN, CCRC
          • Phone Number: 256-533-6603
        • Principal Investigator:
          • Michael Carter, MD
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Arkansas Urology Research Center
        • Contact:
          • Jonathan Rushing
          • Phone Number: 501-410-1100
        • Principal Investigator:
          • Ralph J. Henderson, MD
    • California
      • Los Angeles, California, United States, 90017
        • Recruiting
        • Urology Group of Southern California
        • Principal Investigator:
          • John Kowalczyk, DO
        • Contact:
          • Phone Number: 213-977-1176
      • Murrieta, California, United States, 92562
        • Recruiting
        • Tri Valley Urology Medical Group
        • Contact:
        • Principal Investigator:
          • Varun R. Talanki, MD
        • Sub-Investigator:
          • Philip P. Brodak, MD, FACS
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • Innovation Medical Group LLC (Endo Care of South Florida)
        • Contact:
          • Phone Number: 855-844-1545
        • Principal Investigator:
          • Ihosvani Miguel, MD
      • Miami, Florida, United States, 33186
        • Recruiting
        • Coral Research Clinic
        • Principal Investigator:
          • Jorge Paoli-Bruno, MD
        • Contact:
          • Phone Number: 708-362-6114
      • Miami, Florida, United States, 33135
        • Recruiting
        • Clintex Research Group
        • Contact:
        • Principal Investigator:
          • Harvey Samowitz, MD
      • North Miami Beach, Florida, United States, 33162
        • Recruiting
        • Harmony Clinical Research
        • Contact:
        • Principal Investigator:
          • Howard Reinfeld, MD
      • Palmetto Bay, Florida, United States, 33157
        • Recruiting
        • Innovation Clinical Trials: Medical Reseach Center
        • Contact:
          • Phone Number: 786-298-5170
        • Principal Investigator:
          • Luis Hernandez-Rosado, MD
      • Sunrise, Florida, United States, 33351
        • Recruiting
        • Precision Clinical Research, LLC
        • Contact:
          • Phone Number: 954-915-9991
        • Principal Investigator:
          • Ralph Zagha, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • Alliance for Multispecialty Research, LLC
        • Contact:
          • Phone Number: 702-545-6840
        • Principal Investigator:
          • Michael Jacobs, MD, PhD
    • New York
      • Garden City, New York, United States, 11530
        • Recruiting
        • AccuMed Research Associates
        • Contact:
        • Principal Investigator:
          • Mitchell D. Efros, MD
      • Rochester, New York, United States, 14609
        • Recruiting
        • Rochester Clinical Research, Inc
        • Principal Investigator:
          • Matthew Davis, MD
        • Contact:
          • Phone Number: 585-288-0890
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • Alliance for Multispeciaty Research, LLC
        • Contact:
        • Principal Investigator:
          • Richard M. Glover, II, MD
    • Texas
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Mt. Olympus Medical Research Group, LLC
        • Principal Investigator:
          • Harish Thakkar, MD
      • Webster, Texas, United States, 77598
        • Recruiting
        • Tranquil Clinical and Research Consulting Services, LLC
        • Contact:
          • Karim Mohammed
          • Phone Number: 713-907-6054
        • Principal Investigator:
          • Rohit Dhir, MD
    • Virginia
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • Virginia Urology
        • Contact:
          • Phone Number: 804-330-9105
        • Principal Investigator:
          • Joseph H. Ellen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo oral film, on-demand use once per day, at maximum 60 films during a 12-week period
Drug: Placebo
Placebo Oral Film
Other Names:
  • Placebo-controlled
Experimental: Sildenafil
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
Sildenafil Oral Film containing 25 mg, 50 mg, 75 mg or 100 mg sildenafil as citrate, flexible-dose
Other Names:
  • Sildenafil Orodispersible Film

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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")
12 weeks of treatment
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
Baseline to the end of the 12-week treatment period
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
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
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
Between the 4-week pre-treatment period and the end of the 12-week treatment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety TEAE of special interest - headache
Time Frame: Over 12 weeks of treatment as compared to placebo
The incidence of TEAEs of Special Interest of headache
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
The incidence of TEAEs of Special Interest of dizziness
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;
The incidence of TEAEs that may be suggestive of vasomotor drug effects and the proportion of subjects with at least one of these TEAEs
Over 12 weeks of treatment as compared to placebo;

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory efficacy of Sildenafil oral film compared to placebo - attempts
Time Frame: Up to 12 weeks of treatment
Number of attempts for sexual intercourse
Up to 12 weeks of treatment
Exploratory efficacy of Sildenafil oral film compared to placebo - overall treatment satisfaction
Time Frame: Up to 12 weeks of treatment
Mean treatment satisfaction as assessed by Overall Treatment Satisfaction score on a 5-point scale (4=excellent; 3=good; 2=fair; 1=poor; 0=none)
Up to 12 weeks of treatment
Exploratory efficacy of Sildenafil oral film compared to placebo - GAQ
Time Frame: Up to 12 weeks of treatment
Proportion of subject responses to Global Assessment Questionnaire (GAQ) consisting of 2 questions (Yes or No): Question 1 'Has the treatment you have been taking improved your erectile function?' and if necessary, Question 2 'If yes, has the treatment improved your ability to engage in sexual activity?'.
Up to 12 weeks of treatment
Exploratory efficacy of Sildenafil oral film compared to placebo - drug product palatability
Time Frame: Up to 12 weeks of treatment
Subjective measures of the Drug Product Palatability consisting of 5 specific questions: "1. Rate the oral sensation/mouthfeel of the drug product"; "2. Rate the taste of the drug product"; "3. How strong is the taste?"; "4. Rate the aftertaste of the drug product"; and "5. How strong is the aftertaste?". For questions 1, 2, and 4, the range of responses is: "very unpleasant, unpleasant, no sensation/mouthfeel, pleasant, very pleasant." For questions 3 and 5, the range of responses is: "very strong, strong, moderate, mild, no taste".
Up to 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IBSA Institut Biochimique SA

Investigators

  • Principal Investigator: Mitchell D. Efros, MD, AccuMed Research Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

August 4, 2022

First Posted (Actual)

August 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20US-SDF15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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