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Topical Gel

MED3000 Gel for Post-Prostatectomy Erectile Dysfunction

N/A
Recruiting
Led By Martin Kathrins, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying a new therapy for erectile dysfunction after prostate surgery, to see if it's safe and effective.

Who is the study for?
Men aged 40-70 who've had nerve-sparing prostate surgery for low/intermediate-risk cancer 1.5-4 years ago, with ongoing erectile dysfunction despite treatments, in a stable relationship, and no disease recurrence. Excludes those with genital abnormalities or complications from surgery that could affect treatment.
What is being tested?
The trial is testing MED3000 topical gel's effectiveness and safety on men experiencing erectile dysfunction after radical prostatectomy (prostate removal). It aims to see if this gel can help improve sexual function when used as needed before sexual activity.
What are the potential side effects?
While the specific side effects of MED3000 are not listed here, typical side effects of topical gels may include skin irritation at the application site, itching, rash, and potential systemic effects depending on absorption.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effect of MED3000 topical gel on erectile function
Effect of MED3000 topical gel on erectile function after 12 weeks based on minimally clinically important difference
Secondary study objectives
Adverse events of MED3000 topical gel
Change from baseline in all domains of the IIEF.
Efficacy of MED3000 topical gel (SEAR questionnaire)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MED3000 topical gel treatmentExperimental Treatment1 Intervention
All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits.

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Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,841,604 Total Patients Enrolled
Martin Kathrins, MDPrincipal InvestigatorBrigham and Women's Hospital
~8 spots leftby Nov 2025
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