Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction

A Multi-centre, Randomised, Open-label, Home Use, Parallel Group, Clinical Investigation of Topically-applied MED3000 Gel and Oral Tadalafil (5 mg) Tablets for the Treatment of Erectile Dysfunction (ED) Over a 24 Week Period

An open-label investigation using MED3000 gel or tadalafil (5 mg) tablets in the treatment of erectile dysfunction in patients from 22 to 70 years of age. Each patients will be expected to participate for up to 30 weeks. Eligible patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets in a 1:1 ratio.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Device: MED3000 (Male); Device: MED3000 (Female); Drug: Tadalafil 5mg (Male); Drug: Tadalafil 5mg (Female)

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • Medical Center "Asklepii"OOD
  • Plovdiv, Bulgaria, 4002
    • ЕТ "Аssoc. Prof. Stefan Popov - Individual Practice for Specialized Outhospital medical care for Neurology and Pscyhiatry"
  • Plovdiv, Bulgaria
    • UMHAT Plovdiv AD
  • Silistra, Bulgaria, 7500
    • MHAT "Silistra"AD
  • Sofia, Bulgaria, 1000
    • Medical Center "INTERMEDICA"ООD
• Georgia
  • Batumi, Georgia
    • LTD Health
  • Kutaisi, Georgia, 4600
    • JSC "Evex clinics"
  • Rustavi, Georgia, 3700
    • Rustavi N2 Medical Diagnostic Center
  • Tbilisi, Georgia, 0112
    • Clinic "GIDMEDI"
  • Tbilisi, Georgia, 0160
    • JSC "Evex clinics"
  • Tbilisi, Georgia, 0162
    • Raymann LLC
• Poland
  • Katowice, Poland, 40-065
    • The Mikolowska Medical Center
  • Katowice, Poland, 40-611
    • Provita Sp. z o.o.
  • Kraków, Poland, 30-074
    • Medistica Osteomed
  • Lublin, Poland, 20-93
    • PROVITA Specialised Gynecology and Sexology Practice
  • Warsaw, Poland, 05-077
    • Sexology and Pathology of Intercourse Clinic
  • Wrocław, Poland, 53-532
    • Ryszard Smoliński's Medical Cabinet
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male heterosexual patients aged 22-70 years.
• Confirmed clinical diagnosis of mild, moderate or severe ED for more than 3 months.
• Involved in a continuous heterosexual relationship with their partner for at least 6 months.

Exclusion Criteria:

• Any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrinological, metabolic, neurological or psychiatric disease.
• History of unstable medical or psychiatric condition or using any medication that, in the opinion of the Principal Investigator, is likely to affect the patient's ability to complete the investigation or precludes the patient's participation in the investigation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MED3000; MED3000 gel formulation topically applied to the glans penis	Device: MED3000 (Male); Gel formulation; Device: MED3000 (Female); Gel formulation
Experimental: Tadalafil; Tadalafil (5 mg) tablets to be taken orally	Drug: Tadalafil 5mg (Male); Tablets; Drug: Tadalafil 5mg (Female); Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Erectile Function (EF) Domain of the International Index of Erectile Function (IIEF) Questionnaire, in Patients Randomised to MED3000, at Week 24	Co-primary objectives: Demonstrate an improvement compared to baseline of erectile function, in patients randomised to receive MED3000, using the IIEF-EF patient reported outcome instrument.; Observe a mean change from baseline of the IIEF-EF, in patients randomised to MED3000, greater or equal to the minimal clinically importance difference of 4. The IIEF is a validated questionnaire, consisting of 15 questions, for detecting treatment changes in EF. The EF domain of IIEF is derived using questions 1, 2, 3, 4, 5 and 15. A score of 0 to 5 is awarded to each of questions 1 to 5 and a score of 1 to 5 is awarded to question 15. Higher scores indicate better sexual function. Domain score is computed by summing the scores for individual questions. The minimum and maximum possible scores are 1 and 30 respectively. Patients with a score of 21 or less are considered to have ED. Change from baseline = Week 24 score - Baseline score.	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000.	Demonstrate a speed of onset of action from application of MED3000 gel to the time when patient notices their erection starting. Percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within certain period of time, out of the total number of intercourse attempts made using the product during the 24-week treatment period. The certain periods of time are within 15 minutes, 10 minutes and 5 minutes. Percentage of uses is calculated with the denominator equal to the total number of intercourse attempts made using the product during the 24-week treatment period and the numerator equal to the total number of times that the response to the onset of action question 1 indicated a time of 5 (10, 15) minutes or less. Question 1 of the Onset of Action questionnaire: - After application of the gel/taking medication, when did you begin to notice your erection starting?	24 weeks
Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000.	Demonstrate a speed of onset of action from application of MED3000 gel to the time when the patients is able to have penetrative sex. Percentage of MED3000 uses per patient that resulted in the patient being able to have penetrative sex within certain period of time, out of the total number of intercourse attempts made using the product during the 24-week treatment period. The certain periods of time are within 15 minutes, 10 minutes and 5 minutes. Percentage of uses is calculated with the denominator equal to the total number of intercourse attempts made using the product during the 24-week treatment period and the numerator equal to the total number of times that the response to the onset of action question 2 indicated a time of 5 (10, 15) minutes or less. Question 2 of the Onset of Action questionnaire: - After application of the gel/taking medication, when were you able to have penetrative sex?	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
IIEF-EF questionnaire	Estimate a difference between MED3000 and tadalafil in improvement compared to baseline of IIEF-EF	24 weeks
IIEF-EF questionnaire	Evaluate the mean change from baseline (IIEF-EF) at Weeks 4, 8, 12, 16 and 20 post-randomisation	20 weeks
IIEF-EF questionnaire	Evaluate the proportion of patients reporting a meaningful improvement in IIEF-EF scores according to the criteria published by Rosen et al 2011	24 weeks
IIEF questionnaire	Evaluate the mean change from baseline scores in questions 3, and 4 of the IIEF assessed at every 4 weeks after randomisation	24 weeks
IIEF questionnaire	Evaluate the mean change from baseline of other IIEF domains assessed every 4 weeks after randomisation	24 weeks
SEAR questionnaire	Evaluate the sexual intercourse experience using the Self-Esteem And Relationship questionnaire.	24 weeks
Treatment-emergent adverse events	Evaluate the safety of MED3000 and tadalafil using the occurence and severity of treatment-emergent adverse events and standard physical and laboratory assessments.	24 weeks

Collaborators and Investigators

• Sponsor: Futura Medical Developments Ltd.
• Investigators: Principal Investigator: Arthur Burnett, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2021
• Primary Completion (Actual): July 13, 2022
• Study Completion (Actual): July 13, 2022

Study Registration Dates

• First Submitted: July 26, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Tadalafil
• Other Study ID Numbers: FM71

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No