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Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of 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
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing two treatments for erectile dysfunction in men aged 22 to 70. One treatment is a gel applied to the skin, and the other is a pill taken orally. Both treatments work by improving blood flow to help achieve and maintain an erection. Participants will use either the gel or the pill for several months.

Eligible Conditions
  • Erectile Dysfunction

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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 study objectives
IIEF questionnaire
IIEF-EF questionnaire
SEAR questionnaire
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
Tadalafil 5mg (Male)
2021
Completed Phase 3
~120
MED3000 (Female)
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
~27 spots leftby Dec 2025
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