Phase 3
N=192
Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT04984993 ↗Enrolled (actual)
192
Serious AEs
0.5%
Results posted
Sep 2023
Primary outcome: Primary: 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 — 5.73 Score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MED3000 (Male) (Device); Tadalafil 5mg (Male) (Drug); MED3000 (Female) (Device); Tadalafil 5mg (Female) (Drug)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- Male
- Sponsor
- Futura Medical Developments Ltd.
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
5.73 | <0.001 sig |
| SECONDARY Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000. |
62.59; 47.81; 24.01 | <0.001 sig |
| SECONDARY Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000. |
55.70; 31.91; 13.72 | <0.001 sig |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04984993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.