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MED3000 for Erectile Dysfunction

Phase 3
Waitlist Available
Led By Arthur Burnett, MD
Research Sponsored by Futura Medical Developments Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
Secondary outcome measures
Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000.
Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000.
Other outcome measures
IIEF questionnaire
IIEF-EF questionnaire
SEAR questionnaire
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: TadalafilExperimental Treatment2 Interventions
Tadalafil (5 mg) tablets to be taken orally
Group II: MED3000Experimental Treatment2 Interventions
MED3000 gel formulation topically applied to the glans penis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tadalafil 5mg (Female)
2021
Completed Phase 3
~120
MED3000 (Male)
2021
Completed Phase 3
~120
MED3000 (Female)
2021
Completed Phase 3
~120
Tadalafil 5mg (Male)
2021
Completed Phase 3
~120

Find a Location

Who is running the clinical trial?

Futura Medical Developments Ltd.Lead Sponsor
5 Previous Clinical Trials
1,357 Total Patients Enrolled
3 Trials studying Erectile Dysfunction
1,277 Patients Enrolled for Erectile Dysfunction
Arthur Burnett, MDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Pennsylvania
Arizona
Florida
How old are they?
65+
18 - 65
What site did they apply to?
Johns Hopkins University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
2021. "Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04984993.
~32 spots leftby Apr 2025
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