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Completed

NCT Number: NCT05673005

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

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.

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Key information

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MED3000 topical gel

Device

Topical gel that has been shown to improve erectile dysfunction when used as needed.

Primary outcomes

  1. 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

    Time frame: 12 weeks

    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

Secondary outcomes

  1. Efficacy of MED3000 Topical Gel (Self-Esteem and Relationship Questionnaire)

    Time frame: 12 weeks

    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

  2. Change From Baseline in All Domains of the IIEF.

    Time frame: 12 weeks

    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

  3. Adverse Events of MED3000 Topical Gel

    Time frame: 12 weeks

    Treatment-related adverse events in male patients and female partners occurring during treatment with MED3000.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2023
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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