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

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

NA

Target enrollment

20 participants

Primary outcome timeframe

12 weeks

Results posted on

2025-12-30

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=174 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=174 Participants • 1 patient did not meet inclusion criteria
Race (NIH/OMB) Asian	0 Participants n=174 Participants • 1 patient did not meet inclusion criteria
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=174 Participants • 1 patient did not meet inclusion criteria
Race (NIH/OMB) Black or African American	2 Participants n=174 Participants • 1 patient did not meet inclusion criteria
Race (NIH/OMB) White	18 Participants n=174 Participants • 1 patient did not meet inclusion criteria
Race (NIH/OMB) More than one race	0 Participants n=174 Participants • 1 patient did not meet inclusion criteria
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants • 1 patient did not meet inclusion criteria
Sex: Female, Male Female	0 Participants n=174 Participants • one subject did not meet enrollment criteria
Sex: Female, Male Male	20 Participants n=174 Participants • one subject did not meet enrollment criteria

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	MED3000 topical gel treatment n=17 Participants All qualified enrolled patients will receive treatment with MED3000 topical gel on demand through the 12-week follow-up visits.
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 data not reported

SECONDARY outcome

Timeframe: 12 weeks

The efficacy of MED3000 in patients at weeks 4, 8 and 12 (units on a scale) \[EPIC minimum score 18; maximum score 93, with higher scores representing improved function\]

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

The efficacy of MED3000 in patients at weeks 4, 8 and 12 (units on a scale)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

The change from baseline in 24 hour pad weight and usage number per day at 12 weeks. (grams)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

The change from baseline of the stretched flaccid penile length following 12-weeks of treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome data not reported

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