Erectile Dysfunction Following Radical ProstatectomyNCT05673005
MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction
A study testing MED3000 topical gel in people with Erectile Dysfunction Following Radical Prostatectomy, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy
- What is being tested?
- MED3000 topical gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 9 Aug 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed 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.
- Being tested
- MED3000 topical gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MED3000 topical gelDevice
Topical gel that has been shown to improve erectile dysfunction when used as needed.
| Study group | Role | What they receive |
|---|---|---|
| MED3000 topical gel treatment | Experimental | All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits. Receives: Device: MED3000 topical gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (3)
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
Measured: 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
Measured: 12 weeks
Adverse Events of MED3000 Topical Gel
Treatment-related adverse events in male patients and female partners occurring during treatment with MED3000.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start1 Apr 2023
- Primary completion24 Jul 2024
- Study completion9 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Medical device (MED3000)
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Kathrins, M.D., Brigham and Women's Hospital
- Investigators
- Martin Kathrins, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673005
- Sponsor's protocol ID
- 2021P002976
- Status last verified
- Nov 2025
- First submitted
- 8 Dec 2021
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes