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The investigators are doing this research to evaluate the efficacy and safety of topical MED3000 therapy in men with persistent erectile dysfunction 1.5 to 4 years following radical prostatectomy surgery.
MED3000 is a topical gel that has been developed to treat patients with erectile dysfunction. The investigators postulate that on demand treatment with MED3000 can improve on-demand erectile function among men status-post radical prostatectomy, allowing for some endogenous cavernosal nerve function recovery for 1.5 to 4 years post-surgery among men with normal baseline pre-surgical erectile function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MED3000 topical gel treatment | Experimental | All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MED3000 topical gel | Device | Topical gel that has been shown to improve erectile dysfunction when used as needed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Whether the Erectile Function Domain of the International Index of Erectile Function Mean Change From Baseline Met or Exceeded the Minimally Clinically Important Difference (MCID) of 4 | To investigate the effect of MED3000 topical gel for treatment of erectile dysfunction after nerve sparing prostatectomy (based on Erectile Function domain of the International Index of Erectile Function) (units on a scale) and whether it met MCID criteria of change of mean 4 [IIEF EF minimum score is 0, maximum score is 75, with higher scores representing improved erectile function); units on a scale](streamdown:incomplete-link) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of MED3000 Topical Gel (Self-Esteem and Relationship Questionnaire) | The efficacy of MED3000 in patients at weeks 4, 8 and 12 using: The change from baseline in Self-Esteem and Relationship (SEAR) questionnaire for men (units on a scale) [SEAR minimum score is 0, maximum score is 70, with higher scores representing improved outcomes); units on a scale](streamdown:incomplete-link) | 12 weeks |
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Inclusion Criteria:
Men who underwent robotic bilateral nerve-sparing radical prostatectomy between 18 and 36 months prior to study commencement
Subjects are 18-48 months status-post radical prostatectomy
Subjects have any degree of erectile dysfunction based on IIEF questionnaire
Age 40 - 70 at study commencement
Diagnosed with low/intermediate-risk prostate cancer:
Normal pre-radical prostatectomy erectile function (IIEF >=26) or equivalent response on EPIC
Baseline erectile dysfunction at time of screening (despite use of erectogenic aids of any kind) and enrolment following washout (IIEF-ED domain <=25)
Sexually active, in a stable heterosexual relationship for at least 6 months prior to screening
Able to understand and complete patient questionnaires
Serum prostate specific antigen (PSA) undetectable (no evidence of disease recurrence)
Able to consent to participate
Documented written informed consent from both patient and his female partner
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Kathrins, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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20 patients met all the eligibility criteria and enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | MED3000 Topical Gel Treatment | All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits. MED3000 topical gel: Topical gel that has been shown to improve erectile dysfunction when used as needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1 patient did not meet enrollment criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | MED3000 Topical Gel Treatment | All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Whether the Erectile Function Domain of the International Index of Erectile Function Mean Change From Baseline Met or Exceeded the Minimally Clinically Important Difference (MCID) of 4 | To investigate the effect of MED3000 topical gel for treatment of erectile dysfunction after nerve sparing prostatectomy (based on Erectile Function domain of the International Index of Erectile Function) (units on a scale) and whether it met MCID criteria of change of mean 4 [IIEF EF minimum score is 0, maximum score is 75, with higher scores representing improved erectile function); units on a scale](streamdown:incomplete-link) | Posted | Mean | Standard Deviation | IIEF-EF difference (units on scale) | 12 weeks |
|
From enrollment until end of follow-up
No adverse events, local reactions, or difficulty with application reported by any participant over the 12-week period.
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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 Topical Gel Treatment | All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martin Kathrins, MD | Mass General Brigham Department of Urology | 617-732-6227 | mkathrins@bwh.harvard.edu |
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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 | Nov 2, 2023 | Oct 17, 2025 | Prot_SAP_000.pdf |
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Medical device (MED3000)
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| Change From Baseline in All Domains of the IIEF. | The efficacy of MED3000 in patients at weeks 4, 8 and 12 (units on a scale). To investigate the effect of MED3000 topical gel for treatment of erectile dysfunction after nerve sparing prostatectomy (based on Erectile Function domain of the International Index of Erectile Function) (units on a scale) and whether it changed over time [IIEF EF minimum score is 0, maximum score is 75, with higher scores representing improved erectile function]; units on a scale | 12 weeks |
| Adverse Events of MED3000 Topical Gel | Treatment-related adverse events in male patients and female partners occurring during treatment with MED3000. | 12 weeks |
| years |
|
| Race (NIH/OMB) | 1 patient did not meet inclusion criteria | Count of Participants | Participants |
|
| Sex: Female, Male | one subject did not meet enrollment criteria | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Efficacy of MED3000 Topical Gel (Self-Esteem and Relationship Questionnaire) | The efficacy of MED3000 in patients at weeks 4, 8 and 12 using: The change from baseline in Self-Esteem and Relationship (SEAR) questionnaire for men (units on a scale) [SEAR minimum score is 0, maximum score is 70, with higher scores representing improved outcomes); units on a scale](streamdown:incomplete-link) | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks |
|
|
|
| Secondary | Change From Baseline in All Domains of the IIEF. | The efficacy of MED3000 in patients at weeks 4, 8 and 12 (units on a scale). To investigate the effect of MED3000 topical gel for treatment of erectile dysfunction after nerve sparing prostatectomy (based on Erectile Function domain of the International Index of Erectile Function) (units on a scale) and whether it changed over time [IIEF EF minimum score is 0, maximum score is 75, with higher scores representing improved erectile function]; units on a scale | Posted | Mean | Standard Deviation | Units on a scale | 12 weeks |
|
|
|
| Secondary | Adverse Events of MED3000 Topical Gel | Treatment-related adverse events in male patients and female partners occurring during treatment with MED3000. | Posted | Count of Participants | Participants | 12 weeks |
|
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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