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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Topical gel that has been shown to improve erectile dysfunction when used as needed.
Brigham and Women's Hospital
Boston, Massachusetts, United States
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
Adverse Events of MED3000 Topical Gel
Treatment-related adverse events in male patients and female partners occurring during treatment with MED3000.
Time frame: 12 weeks
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