Erectile Dysfunction Following Radical Prostatectomy Clinical Trial
Official title:
MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction
NCT number | NCT05673005 |
Other study ID # | 2021P002976 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2023 |
Est. completion date | April 2024 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | April 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | 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: - PSA < 20 ng/ml - Gleason score =< 8 - Prostate Cancer stage =< T3a - 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: - Anatomical abnormalities in the genitalia or pelvic region such as severe phimosis - 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) - Tumor upstaging beyond T3a - Incomplete / sub-total nerve sparing on either side - Previous or scheduled treatment with pelvic salvage radiotherapy and/or androgen deprivation therapy - Prior receipt of androgen deprivation therapy - Any other condition that would prevent the patient from completing the study, as judged by the Principal Investigator |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of MED3000 topical gel on erectile function | 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) | 12 weeks | |
Primary | Effect of MED3000 topical gel on erectile function after 12 weeks based on minimally clinically important difference | 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. | 12 weeks | |
Secondary | Efficacy of MED3000 topical gel (SEAR 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 |
12 weeks | |
Secondary | The change from baseline in Urinary incontinence using the Expanded Prostate Cancer Index Composite (EPIC) (Efficacy) | The efficacy of MED3000 in patients at weeks 4, 8 and 12 | 12 weeks | |
Secondary | Change from baseline in all domains of the IIEF. | The efficacy of MED3000 in patients at weeks 4, 8 and 12 | 12 weeks | |
Secondary | Efficacy of MED3000 topical gel on post-prostatectomy incontinence | The change from baseline in 24 hour pad weight and usage number per day at 12 weeks. | 12 weeks | |
Secondary | Efficacy of MED3000 topical gel on stretched flaccid penile length | The change from baseline of the stretched flaccid penile length following 12-weeks of treatment | 12 weeks | |
Secondary | Adverse events of MED3000 topical gel | Treatment-related adverse events in male patients and female partners occurring during treatment with MED3000. | 12 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
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