Trial · NCT04984993
Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
NCT04984993, Phase 3, Completed, Futura Medical Developments Ltd.; results first posted 2023-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction. Trials, record NCT04984993. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04984993
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Investigation Using MED3000 Gel or Tadalafil Tablets in the Treatment of Erectile Dysfunction
- NCT number
- NCT04984993
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 116 participants, actual
- Lead sponsor
- Futura Medical Developments Ltd.
- Conditions
- Erectile Dysfunction
- Interventions
- MED3000 (Male), Tadalafil 5mg (Male), MED3000 (Female), Tadalafil 5mg (Female)
- First posted
- 2021-08-02
- Last updated
- 2023-09-21
- Results first posted
- 2023-09-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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 of 1 to 5 is awarded to question 15. Higher scores indicate better sexual function. Domain score is computed by summing the scores for individual questions. The minimum and maximum possible scores are 1 and 30 respectively. Patients with a score of 21 or less are considered to have ED. Change from baseline = Week 24 score - Baseline score. |
| Secondary | Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000. | 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 treatment period and the numerator equal to the total number of times that the response to the onset of action question 1 indicated a time of 5 (10, 15) minutes or less. Question 1 of the Onset of Action questionnaire: \- After application of the gel/taking medication, when did you begin to notice your erection starting? |
| Secondary | Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000. | 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 treatment period and the numerator equal to the total number of times that the response to the onset of action question 2 indicated a time of 5 (10, 15) minutes or less. Question 2 of the Onset of Action questionnaire: \- After application of the gel/taking medication, when were you able to have penetrative sex? |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Baseline and Week 24 | MED3000 randomised patients (the only group considered for this outcome). Week 24 values for patients who do not have a Week 24 IIEF-EF value due to early treatment discontinuation adversely related to randomised treatment were imputed as baseline value resulting in zero change from baseline. Week 24 values for patients with early termination discontinuation not adversely related to randomised treatment were imputed via multiple imputation method. | Score on a scale | MEAN |
| SECONDARY | Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000. | 24 weeks | MED3000 randomised patients (the only group considered for this outcome) | percentage of uses per patient | MEAN |
| SECONDARY | Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000. | 24 weeks | MED3000 randomised patients (the only group considered for this outcome) | percentage of uses per patient | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | MED3000 | 5.73 | Standard Error 1.00 | Score on a scale | |
| Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000. | MED3000 | 15 minutes | 62.59 | Standard Deviation 39.18 | percentage of uses per patient |
| Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000. | MED3000 | 10 minutes | 47.81 | Standard Deviation 36.26 | percentage of uses per patient |
| Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000. | MED3000 | 5 minutes | 24.01 | Standard Deviation 33.43 | percentage of uses per patient |
| Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000. | MED3000 | 15 minutes | 55.70 | Standard Deviation 36.13 | percentage of uses per patient |
| Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000. | MED3000 | 10 minutes | 31.91 | Standard Deviation 29.30 | percentage of uses per patient |
| Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000. | MED3000 | 5 minutes | 13.72 | Standard Deviation 22.33 | percentage of uses per patient |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MED3000 | 96 | |
| Overall Study | STARTED | Tadalafil | 96 | |
| Overall Study | Received Treatment | MED3000 | 94 | |
| Overall Study | Received Treatment | Tadalafil | 94 | |
| Overall Study | COMPLETED | MED3000 | 82 | |
| Overall Study | COMPLETED | Tadalafil | 92 | |
| Overall Study | NOT COMPLETED | MED3000 | 14 | |
| Overall Study | NOT COMPLETED | Tadalafil | 4 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea (Male) | Gastrointestinal disorders | MED3000 | 2 | 47 | |
| other | Nausea (Male) | Gastrointestinal disorders | Tadalafil | 0 | 47 | |
| other | Non-cardiac chest pain (Male) | General disorders | MED3000 | 0 | 47 | |
| other | Non-cardiac chest pain (Male) | General disorders | Tadalafil | 2 | 47 | |
| other | Back Pain (Male) | Musculoskeletal and connective tissue disorders | MED3000 | 0 | 47 | |
| other | Back Pain (Male) | Musculoskeletal and connective tissue disorders | Tadalafil | 2 | 47 | |
| other | Headache (Male) | Nervous system disorders | MED3000 | 2 | 47 | |
| other | Headache (Male) | Nervous system disorders | Tadalafil | 9 | 47 | |
| other | Headache (Female) | Nervous system disorders | MED3000 | 3 | 47 | |
| other | Headache (Female) | Nervous system disorders | Tadalafil | 0 | 47 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MED3000 | 0 | 94 |
| Total, all-cause mortality | Tadalafil | 0 | 94 |
| Total, other adverse events | MED3000 | 10 | 47 |
| Total, other adverse events | Tadalafil | 16 | 47 |
| Total, serious adverse events | MED3000 | 0 | 94 |
| Total, serious adverse events | Tadalafil | 1 | 94 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MED3000 vs Tadalafil: deaths from any cause | Trial comparisons |
| MED3000 vs Tadalafil: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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