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

Sponsor
Futura Medical Developments Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT04984993
Collaborator
(none)
96
Enrollment
18
Locations
2
Arms
9.4
Actual Duration (Months)
5.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: MED3000
  • Drug: Tadalafil 5mg
 Phase 3

Study Design

Study Type:
Interventional
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 periodPatients 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 :
Sep 29, 2021
Actual Primary Completion Date :
Jul 13, 2022
Actual Study Completion Date :
Jul 13, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. IIEF-EF questionnaire [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 [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) [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) [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 [24 weeks]

    Estimate a difference between MED3000 and tadalafil in improvement compared to baseline of IIEF-EF

  2. IIEF-EF questionnaire [20 weeks]

    Evaluate the mean change from baseline (IIEF-EF) at Weeks 4, 8, 12, 16 and 20 post-randomisation

  3. IIEF-EF questionnaire [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 [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 [24 weeks]

    Evaluate the mean change from baseline of other IIEF domains assessed every 4 weeks after randomisation

  6. SEAR questionnaire [24 weeks]

    Evaluate the sexual intercourse experience using the Self-Esteem And Relationship questionnaire.

  7. Treatment-emergent adverse events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 70 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins University Baltimore Maryland United States 21205
2 Medical Center "Asklepii"OOD Dupnitsa Bulgaria 2600
3 ЕТ "Аssoc. Prof. Stefan Popov - Individual Practice for Specialized Outhospital medical care for Neurology and Pscyhiatry" Plovdiv Bulgaria 4002
4 UMHAT Plovdiv AD Plovdiv Bulgaria
5 MHAT "Silistra"AD Silistra Bulgaria 7500
6 Medical Center "INTERMEDICA"ООD Sofia Bulgaria 1000
7 LTD Health Batumi Georgia
8 Jsc "Evex Clinics" Kutaisi Georgia 4600
9 Rustavi N2 Medical Diagnostic Center Rustavi Georgia 3700
10 Clinic "GIDMEDI" Tbilisi Georgia 0112
11 JSC "Evex clinics" Tbilisi Georgia 0160
12 Raymann LLC Tbilisi Georgia 0162
13 The Mikolowska Medical Center Katowice Poland 40-065
14 Provita Sp. z o.o. Katowice Poland 40-611
15 Medistica Osteomed Kraków Poland 30-074
16 PROVITA Specialised Gynecology and Sexology Practice Lublin Poland 20-93
17 Sexology and Pathology of Intercourse Clinic Warsaw Poland 05-077
18 Ryszard Smoliński's Medical Cabinet Wrocław Poland 53-532

Sponsors and Collaborators

  • Futura Medical Developments Ltd.

Investigators

  • Principal Investigator: Arthur Burnett, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Futura Medical Developments Ltd.
ClinicalTrials.gov Identifier:
NCT04984993
Other Study ID Numbers:
  • FM71
First Posted:
Aug 2, 2021
Last Update Posted:
Jul 29, 2022
Last Verified:
Jul 1, 2021
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:
Erectile Dysfunction
Tadalafil

Study Results

No Results Posted as of Jul 29, 2022