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

NCT04984993 | Completed Phase 3 Results FDA Device

• 1 other identifier: FM71
• Study Type: interventional
• Target: 116
• Locations: 4 countries
• Sites: 18

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000.

  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.

  24 weeks

Study Arms (2)

MED3000

EXPERIMENTAL

MED3000 gel formulation topically applied to the glans penis

Device: MED3000 (Male); Device: MED3000 (Female)

Tadalafil

EXPERIMENTAL

Tadalafil (5 mg) tablets to be taken orally

Drug: Tadalafil 5mg (Male); Drug: Tadalafil 5mg (Female)

Interventions

MED3000 (Male) DEVICE

Gel formulation

MED3000

Tadalafil 5mg (Male) DRUG

Tablets

Tadalafil

MED3000 (Female) DEVICE

Gel formulation

MED3000

Tadalafil 5mg (Female) DRUG

Tablets

Tadalafil

Eligibility Criteria

• Age: 22 Years - 70 Years
• Gender Eligibility Details: Male patients who have had erectile dysfunction for at least 3 months
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Futura Medical Developments Ltd.: lead

Study Sites (18)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Medical Center "Asklepii"OOD

Dupnitsa, 2600, Bulgaria

Location

ЕТ "Аssoc. Prof. Stefan Popov - Individual Practice for Specialized Outhospital medical care for Neurology and Pscyhiatry"

Plovdiv, 4002, Bulgaria

Location

UMHAT Plovdiv AD

Plovdiv, Bulgaria

Location

MHAT "Silistra"AD

Silistra, 7500, Bulgaria

Location

Medical Center "INTERMEDICA"ООD

Sofia, 1000, Bulgaria

Location

LTD Health

Batumi, Georgia

Location

Jsc "Evex Clinics"

Kutaisi, 4600, Georgia

Location

Rustavi N2 Medical Diagnostic Center

Rustavi, 3700, Georgia

Location

Clinic "GIDMEDI"

Tbilisi, 0112, Georgia

Location

JSC "Evex clinics"

Tbilisi, 0160, Georgia

Location

Raymann LLC

Tbilisi, 0162, Georgia

Location

The Mikolowska Medical Center

Katowice, 40-065, Poland

Location

Provita Sp. z o.o.

Katowice, 40-611, Poland

Location

Medistica Osteomed

Krakow, 30-074, Poland

Location

PROVITA Specialised Gynecology and Sexology Practice

Lublin, 20-93, Poland

Location

Sexology and Pathology of Intercourse Clinic

Warsaw, 05-077, Poland

Location

Ryszard Smoliński's Medical Cabinet

Wroclaw, 53-532, Poland

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Andrew Graham, Senior Clinical Project Manager
• Organization: Futura Medical Development Ltd.

Andy.Graham@futuramedical.com

+44 1483 685682

Study Officials

• Arthur Burnett, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets after a 4 -6 week screening period

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 2, 2021
• Study Start: September 14, 2021
• Primary Completion: July 13, 2022
• Study Completion: July 13, 2022
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2021-07

Locations

BU (5); PL (6); US (1); GE (6)