CompletedPhase 3

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

United States, Bulgaria, Georgia116 participantsStarted 2021-09-14

Plain-language 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.

Who can participate

Age range

22 Years – 70 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline and Week 24

Trial details

NCT IDNCT04984993

SponsorFutura Medical Developments Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-07-13

Results submitted2023-06-23

View on ClinicalTrials.gov More Erectile Dysfunction trials