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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04984993
• Other study ID #: FM71
• Status: Completed
• Phase: Phase 3
• Start date: September 14, 2021
• Est. completion date: July 13, 2022

Study information

• Verified date: July 2021
• Source: Futura Medical Developments Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 13, 2022
• Est. primary completion date: July 13, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 22 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Device:
• MED3000 (Male)
Gel formulation

Drug:
• Tadalafil 5mg (Male)
Tablets

Device:
• MED3000 (Female)
Gel formulation

Drug:
• Tadalafil 5mg (Female)
Tablets

Locations

Country	Name	City	State
Bulgaria	Medical Center "Asklepii"OOD	Dupnitsa
Bulgaria	?? "?ssoc. Prof. Stefan Popov - Individual Practice for Specialized Outhospital medical care for Neurology and Pscyhiatry"	Plovdiv
Bulgaria	UMHAT Plovdiv AD	Plovdiv
Bulgaria	MHAT "Silistra"AD	Silistra
Bulgaria	Medical Center "INTERMEDICA"??D	Sofia
Georgia	LTD Health	Batumi
Georgia	Jsc "Evex Clinics"	Kutaisi
Georgia	Rustavi N2 Medical Diagnostic Center	Rustavi
Georgia	Clinic "GIDMEDI"	Tbilisi
Georgia	JSC "Evex clinics"	Tbilisi
Georgia	Raymann LLC	Tbilisi
Poland	Provita Sp. z o.o.	Katowice
Poland	The Mikolowska Medical Center	Katowice
Poland	Medistica Osteomed	Kraków
Poland	PROVITA Specialised Gynecology and Sexology Practice	Lublin
Poland	Sexology and Pathology of Intercourse Clinic	Warsaw
Poland	Ryszard Smolinski's Medical Cabinet	Wroclaw
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Futura Medical Developments Ltd.

Countries where clinical trial is conducted

United States,  Bulgaria,  Georgia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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