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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MED3000 | Experimental | MED3000 gel formulation topically applied to the glans penis |
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| Tadalafil | Experimental | Tadalafil (5 mg) tablets to be taken orally |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MED3000 (Male) | Device | Gel formulation |
| |
| Tadalafil 5mg (Male) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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? |
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Inclusion Criteria:
Exclusion Criteria:
Male patients who have had erectile dysfunction for at least 3 months
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Burnett, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States | ||
| Medical Center "Asklepii"OOD |
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.
The first informed consent was on September 14, 2021 and the last study visit was on June 13, 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | MED3000 | MED3000 gel formulation topically applied to the glans penis MED3000: Gel formulation |
| FG001 | Tadalafil | Tadalafil (5 mg) tablets to be taken orally Tadalafil 5mg: Tablets |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2022 |
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Patients will be randomised to receive either MED3000 gel or tadalafil (5 mg) tablets after a 4 -6 week screening period
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| Drug |
Tablets |
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| MED3000 (Female) | Device | Gel formulation |
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| Tadalafil 5mg (Female) | Drug | Tablets |
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| 24 weeks |
| 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? | 24 weeks |
| Dupnitsa |
| 2600 |
| Bulgaria |
| ЕТ "Аssoc. Prof. Stefan Popov - Individual Practice for Specialized Outhospital medical care for Neurology and Pscyhiatry" | Plovdiv | 4002 | Bulgaria |
| UMHAT Plovdiv AD | Plovdiv | Bulgaria |
| MHAT "Silistra"AD | Silistra | 7500 | Bulgaria |
| Medical Center "INTERMEDICA"ООD | Sofia | 1000 | Bulgaria |
| LTD Health | Batumi | Georgia |
| Jsc "Evex Clinics" | Kutaisi | 4600 | Georgia |
| Rustavi N2 Medical Diagnostic Center | Rustavi | 3700 | Georgia |
| Clinic "GIDMEDI" | Tbilisi | 0112 | Georgia |
| JSC "Evex clinics" | Tbilisi | 0160 | Georgia |
| Raymann LLC | Tbilisi | 0162 | Georgia |
| The Mikolowska Medical Center | Katowice | 40-065 | Poland |
| Provita Sp. z o.o. | Katowice | 40-611 | Poland |
| Medistica Osteomed | Krakow | 30-074 | Poland |
| PROVITA Specialised Gynecology and Sexology Practice | Lublin | 20-93 | Poland |
| Sexology and Pathology of Intercourse Clinic | Warsaw | 05-077 | Poland |
| Ryszard Smoliński's Medical Cabinet | Wroclaw | 53-532 | Poland |
| Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Regional enrolment details are combined for both the male participants and their female partners.
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| ID | Title | Description |
|---|---|---|
| BG000 | MED3000 | MED3000 gel formulation topically applied to the glans penis MED3000: Gel formulation |
| BG001 | Tadalafil | Tadalafil (5 mg) tablets to be taken orally Tadalafil 5mg: Tablets |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data are presented separately for male participants and female partners. | Mean | Standard Deviation | Years |
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| Age, Continuous | Data are presented separately for male participants and female partners. | Median | Full Range | Years |
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| Age, Customized | Data are presented separately for male participants and female partners. | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity for male & female participants | Count of Participants | Participants |
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| Region of Enrollment | Data are presented for both male and female participants | Count of Participants | Participants |
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| Height | Data are presented for male participants only as not measured in the females | Mean | Standard Deviation | cm |
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| Height | Data are presented for male participants only as not collected in females | Median | Full Range | cm |
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| Weight | Data are presented for male participants only and not measured in females | Mean | Standard Deviation | kg |
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| Weight | Data are presented for male participants only as not collected for females | Median | Full Range | kg |
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| Body Mass Index | Data are presented for male participants only as not determined in females | Mean | Standard Deviation | kg/m2 |
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| Body Mass Index | Data are presented for male participants only as not determined in females | Median | Full Range | kg/m2 |
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| Baseline Erectile Dysfunction (ED) severity | Mild ED = IIEF-EF domain score of 17-25, Moderate ED = IIEF-EF domain score of 11-16, Severe ED = IIEF-EF domain score of <= 10. | Data are presented for male participants only as not relevant for females | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
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. | 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. | Posted | Mean | Standard Error | Score on a scale | Baseline and Week 24 |
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| 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? | MED3000 randomised patients (the only group considered for this outcome) | Posted | Mean | Standard Deviation | percentage of uses per patient | 24 weeks |
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| 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? | MED3000 randomised patients (the only group considered for this outcome) | Posted | Mean | Standard Deviation | percentage of uses per patient | 24 weeks |
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29 Weeks
Both patients and their female partners were monitored for AEs in the study. In the Other (not including SAE) section, AEs have been separated into those experienced by males and those experienced by their females. For this reason the risk value is recorded as 47 in this section. However, the risk value in the SAE and All-mortality sections is 94 which represents both the male and female participants combined.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MED3000 | MED3000 gel formulation topically applied to the glans penis MED3000: Gel formulation | 0 | 94 | 0 | 94 | 10 | 47 |
| EG001 | Tadalafil | Tadalafil (5 mg) tablets to be taken orally Tadalafil 5mg: Tablets | 0 | 94 | 1 | 94 | 16 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA (24.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea (Male) | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
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| Non-cardiac chest pain (Male) | General disorders | MedDRA (24.1) | Systematic Assessment |
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| Back Pain (Male) | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
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| Headache (Male) | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
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| Headache (Female) | Nervous system disorders | MedDRA (24.1) | Systematic Assessment |
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| Abdominal distension (Male) | Gastrointestinal disorders | MedDRA (24.1) | Systematic Assessment |
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| Gamma-glutamyltransferase increased (Male) | Investigations | MedDRA (24.1) | Systematic Assessment |
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| Pain in extremity (Male) | Musculoskeletal and connective tissue disorders | MedDRA (24.1) | Systematic Assessment |
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After completion, the results of the clinical investigation (CI) may be published (first publication shall be referred to as the "Primary Paper"). Results of the CI shall not be published before the primary paper after which PIs may propose publications, including or based on results of the CI, to the Sponsor for review at least 2 months before the planned submission for publication or public disclosure. The Sponsor will provide written approval or reasoned refusal for submission or disclosure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Graham, Senior Clinical Project Manager | Futura Medical Development Ltd. | +44 1483 685682 | Andy.Graham@futuramedical.com |
| Aug 21, 2023 |
| Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D026121 | Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
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