Erectile Dysfunction
Conditions
Brief 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.
Interventions
DEVICEMED3000 (Male)
Gel formulation
Tablets
DEVICEMED3000 (Female)
Gel formulation
DRUGTadalafil 5mg (Female)
Tablets
Sponsors
Futura Medical Developments Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets after a 4 -6 week screening period
Eligibility
Sex/Gender
MALE
Age
22 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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? |
| 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? |
Countries
Bulgaria, Georgia, Poland, United States
Participant flow
Recruitment details
The first informed consent was on September 14, 2021 and the last study visit was on June 13, 2022.
Pre-assignment details
Of 232 screened patients (males and females enrolled for eligibility assessment), 192 patients and their partners were randomised to treatment. Of the 40 patients and partners that failed screening, 36 did not satisfy inclusion criteria and 2 were excluded for other reasons.
Participants by arm
| Arm | Count |
|---|---|
| MED3000 MED3000 gel formulation topically applied to the glans penis
MED3000: Gel formulation | 96 |
| Tadalafil Tadalafil (5 mg) tablets to be taken orally
Tadalafil 5mg: Tablets | 96 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Both patients moved to another country | 4 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 8 | 2 |
Baseline characteristics
| Characteristic | MED3000 | Tadalafil | Total |
|---|---|---|---|
| Age, Continuous Female | 39.5 Years | 38.0 Years | 39.0 Years |
| Age, Continuous Male | 44.5 Years | 39.0 Years | 40.5 Years |
| Age, Customized Female <22 | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized Female 22-29 | 10 Participants | 8 Participants | 18 Participants |
| Age, Customized Female 30-39 | 13 Participants | 18 Participants | 31 Participants |
| Age, Customized Female 40-49 | 3 Participants | 11 Participants | 14 Participants |
| Age, Customized Female 50-59 | 16 Participants | 7 Participants | 23 Participants |
| Age, Customized Female 60-70 | 5 Participants | 3 Participants | 8 Participants |
| Age, Customized Male <22 | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Male 22-29 | 5 Participants | 7 Participants | 12 Participants |
| Age, Customized Male 30-39 | 16 Participants | 18 Participants | 34 Participants |
| Age, Customized Male 40-49 | 5 Participants | 13 Participants | 18 Participants |
| Age, Customized Male 50-59 | 10 Participants | 5 Participants | 15 Participants |
| Age, Customized Male 60-70 | 12 Participants | 5 Participants | 17 Participants |
| Baseline Erectile Dysfunction (ED) severity Mild | 19 Participants | 19 Participants | 38 Participants |
| Baseline Erectile Dysfunction (ED) severity Moderate | 17 Participants | 17 Participants | 34 Participants |
| Baseline Erectile Dysfunction (ED) severity Severe | 12 Participants | 12 Participants | 24 Participants |
| Body Mass Index | 26.985 kg/m2 | 26.759 kg/m2 | 26.959 kg/m2 |
| Ethnicity (NIH/OMB) Female Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Female Not Hispanic or Latino | 48 Participants | 48 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Female Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Male Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Male Not Hispanic or Latino | 48 Participants | 48 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Male Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 179.20 cm STANDARD_DEVIATION 7.24 | 179.43 cm STANDARD_DEVIATION 7.66 | 179.31 cm STANDARD_DEVIATION 7.41 |
| Region of Enrollment Bulgaria | 4 Participants | 2 Participants | 6 Participants |
| Region of Enrollment Georgia | 32 Participants | 28 Participants | 60 Participants |
| Region of Enrollment Poland | 52 Participants | 56 Participants | 108 Participants |
| Region of Enrollment United States | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Female | 48 Participants | 48 Participants | 96 Participants |
| Sex: Female, Male Male | 48 Participants | 48 Participants | 96 Participants |
| Weight | 85.70 kg | 88.19 kg STANDARD_DEVIATION 13.72 | 85.35 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 94 |
| other Total, other adverse events | 10 / 47 | 16 / 47 |
| serious Total, serious adverse events | 0 / 94 | 1 / 94 |
Outcome results
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
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.
Time frame: Baseline and Week 24
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MED3000 | 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 | Standard Error 1 |
Comparison: Null hypothesis: mu \<= 0 versus alternative hypothesis: mu \>0, where mu is the population mean change from baseline in the EF domain of the IIEF questionnaire at week 24.p-value: <0.001t-test, 1 sided
Secondary
Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000.
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?
Time frame: 24 weeks
Population: MED3000 randomised patients (the only group considered for this outcome)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MED3000 | Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000. | 15 minutes | 55.70 percentage of uses per patient | Standard Deviation 36.13 |
| MED3000 | Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000. | 10 minutes | 31.91 percentage of uses per patient | Standard Deviation 29.3 |
| MED3000 | Percentage of Uses Per Patient That Led to an Onset of Action Within a Certain Period of Time in Patients Randomised to MED3000. | 5 minutes | 13.72 percentage of uses per patient | Standard Deviation 22.33 |
p-value: <0.001t-test, 1 sided
p-value: 0.3327t-test, 1 sided
p-value: >0.999t-test, 1 sided
Secondary
Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000.
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?
Time frame: 24 weeks
Population: MED3000 randomised patients (the only group considered for this outcome)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MED3000 | Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000. | 15 minutes | 62.59 percentage of uses per patient | Standard Deviation 39.18 |
| MED3000 | Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000. | 10 minutes | 47.81 percentage of uses per patient | Standard Deviation 36.26 |
| MED3000 | Percentage of Uses Per Patient That Led to an Onset of Erection Within a Certain Period of Time in Patients Randomised to MED3000. | 5 minutes | 24.01 percentage of uses per patient | Standard Deviation 33.43 |
Comparison: Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 15 minutes.p-value: <0.001t-test, 1 sided
Comparison: Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 10 minutes.p-value: <0.001t-test, 1 sided
Comparison: Null hypothesis: mu \<= 30 versus alternative hypothesis: mu \>30, where mu is the population mean percentage of MED3000 uses per patient that resulted in the patient noticing their erection starting within 5 minutes.p-value: 0.89t-test, 1 sided