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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Adverse events of MED3000 topical gel

Change from baseline in all domains of the IIEF.

Efficacy of MED3000 topical gel (SEAR questionnaire)

+3 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,609 Previous Clinical Trials

11,470,307 Total Patients Enrolled

Martin Kathrins, MDPrincipal InvestigatorBrigham and Women's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do participants need to be under a certain age in order to qualify for this trial?

"Based on the trial's selection criteria, individuals aged 40 to 70 are eligible for enrolment."

Answered by AI

Who meets the eligibility criteria to enroll in this trial?

"Aspiring participants of this trial must present with erectile dysfunction and be between 40-70 years old. The study has room for approximately 20 individuals."

Answered by AI

Are there any vacancies left for participants in this investigation?

"This research study is recruiting participants, with its original posting on April 1st 2023 and most recent update being October 25th of the same year. Clinicaltrials.gov contains this information for potential candidates to review."

Answered by AI

How many participants are being enrolled in this study?

"Indeed, the information found on clinicaltrials.gov reveals that this experiment is actively looking for participants. This trial was initially advertised on April 1st 2023 and has been recently refreshed as of October 25th 2023. Solely one medical centre are recruiting twenty individuals to participate in this study."

Answered by AI

What core purpose does this research endeavor seek to achieve?

"This clinical trial will span 12 weeks, with the aim of determining MED3000 topical gel's effect on erectile function after that period. Secondary objectives include assessing its impact on post-prostatectomy incontinence (using 24-hour pad weight and daily usage change from baseline), any treatment-related adverse events among male patients and female partners, as well as changes in self-esteem/relationships using a SEAR questionnaire at 4-, 8-, and 12-week intervals."

Answered by AI