Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT05673005
Status:
COMPLETED
Last Update Posted:
2025-10-06
First Post:
2021-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-04', 'mcpReleaseN': 5, 'releaseDate': '2025-10-17'}, {'resetDate': '2025-12-08', 'mcpReleaseN': 6, 'releaseDate': '2025-11-18'}, {'releaseDate': '2025-12-09'}], 'estimatedResultsFirstSubmitDate': '2025-10-17'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Medical device (MED3000)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2021-12-08', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of MED3000 topical gel on erectile function', 'timeFrame': '12 weeks', 'description': '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)'}, {'measure': 'Effect of MED3000 topical gel on erectile function after 12 weeks based on minimally clinically important difference', 'timeFrame': '12 weeks', 'description': 'To observe a mean change from baseline of the IIEF-EF domain in patients after nerve sparing prostatectomy treated with MED3000, assessed at treatment completion after 12 weeks, greater than or equal to the minimally clinically important difference (MCID) of 4.'}], 'secondaryOutcomes': [{'measure': 'Efficacy of MED3000 topical gel (SEAR questionnaire)', 'timeFrame': '12 weeks', 'description': 'The efficacy of MED3000 in patients at weeks 4, 8 and 12 using:\n\nThe change from baseline in Self-Esteem and Relationship (SEAR) questionnaire for men'}, {'measure': 'The change from baseline in Urinary incontinence using the Expanded Prostate Cancer Index Composite (EPIC) (Efficacy)', 'timeFrame': '12 weeks', 'description': 'The efficacy of MED3000 in patients at weeks 4, 8 and 12'}, {'measure': 'Change from baseline in all domains of the IIEF.', 'timeFrame': '12 weeks', 'description': 'The efficacy of MED3000 in patients at weeks 4, 8 and 12'}, {'measure': 'Efficacy of MED3000 topical gel on post-prostatectomy incontinence', 'timeFrame': '12 weeks', 'description': 'The change from baseline in 24 hour pad weight and usage number per day at 12 weeks.'}, {'measure': 'Efficacy of MED3000 topical gel on stretched flaccid penile length', 'timeFrame': '12 weeks', 'description': 'The change from baseline of the stretched flaccid penile length following 12-weeks of treatment'}, {'measure': 'Adverse events of MED3000 topical gel', 'timeFrame': '12 weeks', 'description': 'Treatment-related adverse events in male patients and female partners occurring during treatment with MED3000.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Erectile Dysfunction Following Radical Prostatectomy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men who underwent robotic bilateral nerve-sparing radical prostatectomy between 18 and 36 months prior to study commencement\n* Subjects are 18-48 months status-post radical prostatectomy\n* Subjects have any degree of erectile dysfunction based on IIEF questionnaire\n* Age 40 - 70 at study commencement\n* Diagnosed with low/intermediate-risk prostate cancer:\n\n * PSA \\< 20 ng/ml\n * Gleason score =\\< 8\n * Prostate Cancer stage =\\< T3a\n* Normal pre-radical prostatectomy erectile function (IIEF \\>=26) or equivalent response on EPIC\n* Baseline erectile dysfunction at time of screening (despite use of erectogenic aids of any kind) and enrolment following washout (IIEF-ED domain \\<=25)\n* Sexually active, in a stable heterosexual relationship for at least 6 months prior to screening\n* Able to understand and complete patient questionnaires\n* Serum prostate specific antigen (PSA) undetectable (no evidence of disease recurrence)\n* Able to consent to participate\n* Documented written informed consent from both patient and his female partner\n\nExclusion Criteria:\n\n* Anatomical abnormalities in the genitalia or pelvic region such as severe phimosis\n* Post-Radical Prostatectomy complications that could impact safety or effectiveness of medical therapy for erectile function (treatment for pelvic hematoma, urinary or intestinal fistula, unresolved anastomotic leak)\n* Tumor upstaging beyond T3a\n* Incomplete / sub-total nerve sparing on either side\n* Previous or scheduled treatment with pelvic salvage radiotherapy and/or androgen deprivation therapy\n* Prior receipt of androgen deprivation therapy\n* Any other condition that would prevent the patient from completing the study, as judged by the Principal Investigator'}, 'identificationModule': {'nctId': 'NCT05673005', 'briefTitle': 'MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction', 'orgStudyIdInfo': {'id': '2021P002976'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MED3000 topical gel treatment', 'description': 'All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits.', 'interventionNames': ['Device: MED3000 topical gel']}], 'interventions': [{'name': 'MED3000 topical gel', 'type': 'DEVICE', 'description': 'Topical gel that has been shown to improve erectile dysfunction when used as needed.', 'armGroupLabels': ['MED3000 topical gel treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Martin Kathrins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Martin Kathrins, M.D.', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}