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

Primary Purpose

Erectile Dysfunction

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MED3000 (Male)
Tadalafil 5mg (Male)
MED3000 (Female)
Tadalafil 5mg (Female)
Sponsored by
Futura Medical Developments Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

22 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins University
  • Medical Center "Asklepii"OOD
  • ЕТ "Аssoc. Prof. Stefan Popov - Individual Practice for Specialized Outhospital medical care for Neurology and Pscyhiatry"
  • UMHAT Plovdiv AD
  • MHAT "Silistra"AD
  • Medical Center "INTERMEDICA"ООD
  • LTD Health
  • Jsc "Evex Clinics"
  • Rustavi N2 Medical Diagnostic Center
  • Clinic "GIDMEDI"
  • JSC "Evex clinics"
  • Raymann LLC
  • The Mikolowska Medical Center
  • Provita Sp. z o.o.
  • Medistica Osteomed
  • PROVITA Specialised Gynecology and Sexology Practice
  • Sexology and Pathology of Intercourse Clinic
  • Ryszard Smoliński's Medical Cabinet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MED3000

Tadalafil

Arm Description

MED3000 gel formulation topically applied to the glans penis

Tadalafil (5 mg) tablets to be taken orally

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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?
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?

Full Information

First Posted
July 26, 2021
Last Updated
September 18, 2023
Sponsor
Futura Medical Developments Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04984993
Brief Title
Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
July 13, 2022 (Actual)
Study Completion Date
July 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Futura Medical Developments Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets after a 4 -6 week screening period
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MED3000
Arm Type
Experimental
Arm Description
MED3000 gel formulation topically applied to the glans penis
Arm Title
Tadalafil
Arm Type
Experimental
Arm Description
Tadalafil (5 mg) tablets to be taken orally
Intervention Type
Device
Intervention Name(s)
MED3000 (Male)
Intervention Description
Gel formulation
Intervention Type
Drug
Intervention Name(s)
Tadalafil 5mg (Male)
Intervention Description
Tablets
Intervention Type
Device
Intervention Name(s)
MED3000 (Female)
Intervention Description
Gel formulation
Intervention Type
Drug
Intervention Name(s)
Tadalafil 5mg (Female)
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000.
Description
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?
Time Frame
24 weeks
Title
Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000.
Description
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?
Time Frame
24 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male patients who have had erectile dysfunction for at least 3 months
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur Burnett, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Medical Center "Asklepii"OOD
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
ЕТ "Аssoc. Prof. Stefan Popov - Individual Practice for Specialized Outhospital medical care for Neurology and Pscyhiatry"
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Facility Name
UMHAT Plovdiv AD
City
Plovdiv
Country
Bulgaria
Facility Name
MHAT "Silistra"AD
City
Silistra
ZIP/Postal Code
7500
Country
Bulgaria
Facility Name
Medical Center "INTERMEDICA"ООD
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
LTD Health
City
Batumi
Country
Georgia
Facility Name
Jsc "Evex Clinics"
City
Kutaisi
ZIP/Postal Code
4600
Country
Georgia
Facility Name
Rustavi N2 Medical Diagnostic Center
City
Rustavi
ZIP/Postal Code
3700
Country
Georgia
Facility Name
Clinic "GIDMEDI"
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
JSC "Evex clinics"
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Raymann LLC
City
Tbilisi
ZIP/Postal Code
0162
Country
Georgia
Facility Name
The Mikolowska Medical Center
City
Katowice
ZIP/Postal Code
40-065
Country
Poland
Facility Name
Provita Sp. z o.o.
City
Katowice
ZIP/Postal Code
40-611
Country
Poland
Facility Name
Medistica Osteomed
City
Kraków
ZIP/Postal Code
30-074
Country
Poland
Facility Name
PROVITA Specialised Gynecology and Sexology Practice
City
Lublin
ZIP/Postal Code
20-93
Country
Poland
Facility Name
Sexology and Pathology of Intercourse Clinic
City
Warsaw
ZIP/Postal Code
05-077
Country
Poland
Facility Name
Ryszard Smoliński's Medical Cabinet
City
Wrocław
ZIP/Postal Code
53-532
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

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