MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction

Erectile Dysfunction Following Radical Prostatectomy Clinical Trial

Official title:

MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673005
• Other study ID #: 2021P002976
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Brigham and Women's Hospital
• Contact: Martin Kathrins
• Phone: 617-732-6227
• Email: mkathrins[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy

Intervention

Device:
• MED3000 topical gel
Topical gel that has been shown to improve erectile dysfunction when used as needed.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

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