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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04984993
Recruitment Status : Completed
First Posted : August 2, 2021
Last Update Posted : July 29, 2022
Sponsor:
Information provided by (Responsible Party):
Futura Medical Developments Ltd.

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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Device: MED3000 Drug: Tadalafil 5mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : September 29, 2021
Actual Primary Completion Date : July 13, 2022
Actual Study Completion Date : July 13, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil

Arm Intervention/treatment
Experimental: MED3000
MED3000 gel formulation topically applied to the glans penis
Device: MED3000
Gel formulation

Experimental: Tadalafil
Tadalafil (5 mg) tablets to be taken orally
Drug: Tadalafil 5mg
Tablets




Primary Outcome Measures :
  1. IIEF-EF questionnaire [ Time Frame: 24 weeks ]
    Demonstrate an improvement of erectile function in patients randomised to receive MED3000 using the IIEF-EF patient reported out outcome instrument.

  2. IIEF-EF questionnaire [ Time Frame: 24 weeks ]
    Observe a mean change from baseline (IIEF-EF) is greater or equal to the minimal clinically importance difference as published in Rosen et al 2011


Secondary Outcome Measures :
  1. Onset of action questionnaire (question 1) [ Time Frame: 24 weeks ]
    Demonstrate a speed of onset of action from application of MED3000 gel to the time when patient notices their erection starting.

  2. Onset of action questionnaire (question 2) [ Time Frame: 24 weeks ]
    Demonstrate a speed of onset of action from application of MED3000 gel to the time when the patients is able to have penetrative sex.


Other Outcome Measures:
  1. IIEF-EF questionnaire [ Time Frame: 24 weeks ]
    Estimate a difference between MED3000 and tadalafil in improvement compared to baseline of IIEF-EF

  2. IIEF-EF questionnaire [ Time Frame: 20 weeks ]
    Evaluate the mean change from baseline (IIEF-EF) at Weeks 4, 8, 12, 16 and 20 post-randomisation

  3. IIEF-EF questionnaire [ Time Frame: 24 weeks ]
    Evaluate the proportion of patients reporting a meaningful improvement in IIEF-EF scores according to the criteria published by Rosen et al 2011

  4. IIEF questionnaire [ Time Frame: 24 weeks ]
    Evaluate the mean change from baseline scores in questions 3, and 4 of the IIEF assessed at every 4 weeks after randomisation

  5. IIEF questionnaire [ Time Frame: 24 weeks ]
    Evaluate the mean change from baseline of other IIEF domains assessed every 4 weeks after randomisation

  6. SEAR questionnaire [ Time Frame: 24 weeks ]
    Evaluate the sexual intercourse experience using the Self-Esteem And Relationship questionnaire.

  7. Treatment-emergent adverse events [ Time Frame: 24 weeks ]
    Evaluate the safety of MED3000 and tadalafil using the occurence and severity of treatment-emergent adverse events and standard physical and laboratory assessments.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients who have had erectile dysfunction for at least 3 months
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04984993


Locations
Show Show 18 study locations
Sponsors and Collaborators
Futura Medical Developments Ltd.
Investigators
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Principal Investigator: Arthur Burnett, MD Johns Hopkins University
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Responsible Party: Futura Medical Developments Ltd.
ClinicalTrials.gov Identifier: NCT04984993    
Other Study ID Numbers: FM71
First Posted: August 2, 2021    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents