Adults 22 to 70, male only, with Erectile Dysfunction. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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 24Primary· Baseline and Week 24
Co-primary objectives:
* Demonstrate an improvement compared to baseline of erectile function, in patients randomised to receive MED3000, using the IIEF-EF patient reported outcome instrument.
* Observe a mean change from baseline of the IIEF-EF, in patients randomised to MED3000, greater or equal to the minimal clinically importance difference of 4.
The IIEF is a validated questionnaire, consisting of 15 questions, for detecting treatment changes in EF. The EF domain of IIEF is derived using questions 1, 2, 3, 4, 5 and 15. A score of 0 to 5 is awarded to each of questions 1 to 5 and a score
Group
Value
95% CI
MED3000
5.73
± 1.00
Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000.Secondary· 24 weeks
Demonstrate a speed of onset of action from application of MED3000 gel to the time when patient notices their erection starting.
Percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within certain period of time, out of the total number of intercourse attempts made using the product during the 24-week treatment period. The certain periods of time are within 15 minutes, 10 minutes and 5 minutes. Percentage of uses is calculated with the denominator equal to the total number of intercourse attempts made using the product during the 24-week treatme
15 minutes
Group
Value
95% CI
MED3000
62.59
± 39.18
10 minutes
Group
Value
95% CI
MED3000
47.81
± 36.26
5 minutes
Group
Value
95% CI
MED3000
24.01
± 33.43
Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000.Secondary· 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.
Percentage of MED3000 uses per patient that resulted in the patient being able to have penetrative sex within certain period of time, out of the total number of intercourse attempts made using the product during the 24-week treatment period. The certain periods of time are within 15 minutes, 10 minutes and 5 minutes. Percentage of uses is calculated with the denominator equal to the total number of intercourse attempts made using the product during the 24-week
15 minutes
Group
Value
95% CI
MED3000
55.70
± 36.13
10 minutes
Group
Value
95% CI
MED3000
31.91
± 29.30
5 minutes
Group
Value
95% CI
MED3000
13.72
± 22.33
Adverse events — posted to ClinicalTrials.gov
Time frame: 29 Weeks.
Reporting threshold: 2%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Futura Medical Developments Ltd.
Last refreshed: 21 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04984993.