Trial Outcomes & Findings for MED3000 Topical Gel for On-Demand Treatment of Post-Radical Prostatectomy Erectile Dysfunction (NCT NCT05673005)

Last Updated: 2026-03-11

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

12 weeks

Results posted on

2026-03-11

Participant Flow

20 patients met all the eligibility criteria and enrolled in the study.

Participant milestones

Participant milestones
Measure	MED3000 Topical Gel Treatment All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits. MED3000 topical gel: Topical gel that has been shown to improve erectile dysfunction when used as needed.
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 patient did not meet inclusion criteria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MED3000 Topical Gel Treatment n=20 Participants All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits.
Age, Continuous	64.6 years STANDARD_DEVIATION 4.6 • n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants • 1 patient did not meet inclusion criteria
Race (NIH/OMB) Asian	0 Participants n=9 Participants • 1 patient did not meet inclusion criteria
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants • 1 patient did not meet inclusion criteria
Race (NIH/OMB) Black or African American	2 Participants n=9 Participants • 1 patient did not meet inclusion criteria
Race (NIH/OMB) White	18 Participants n=9 Participants • 1 patient did not meet inclusion criteria
Race (NIH/OMB) More than one race	0 Participants n=9 Participants • 1 patient did not meet inclusion criteria
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants • 1 patient did not meet inclusion criteria
Sex: Female, Male Female	0 Participants n=9 Participants • one subject did not meet enrollment criteria
Sex: Female, Male Male	20 Participants n=9 Participants • one subject did not meet enrollment criteria

PRIMARY outcome

Timeframe: 12 weeks

Outcome measures

Outcome measures
Measure	MED3000 Gel Participants n=17 Participants All qualified enrolled patients who received treatment with MED3000 topical gel on demand
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	0.8 IIEF-EF difference (units on scale) Standard Deviation 3.9 • Interval 1.0 to 11.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	MED3000 Gel Participants n=17 Participants All qualified enrolled patients who received treatment with MED3000 topical gel on demand
Efficacy of MED3000 Topical Gel (Self-Esteem and Relationship Questionnaire)	1.5 Units on a scale Standard Deviation 5.7

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	MED3000 Gel Participants n=17 Participants All qualified enrolled patients who received treatment with MED3000 topical gel on demand
Change From Baseline in All Domains of the IIEF.	0.4 Units on a scale Standard Deviation 9.9

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	MED3000 Gel Participants n=19 Participants All qualified enrolled patients who received treatment with MED3000 topical gel on demand
Adverse Events of MED3000 Topical Gel	0 Participants

Adverse Events

MED3000 Topical Gel Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Martin Kathrins, MD

Mass General Brigham Department of Urology

Phone: 617-732-6227

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place