(146) TOPICAL ADMINISTRATION OF MED3000 GEL SIGNIFICANTLY IMPROVES ERECTILE FUNCTION IN MEN WITH MILD, MODERATE, OR SEVERE ERECTILE DYSFUNCTION: RESULTS FROM TWO MULTICENTER CLINICAL TRIALS
Authors: Honig S , Brock G , Yafi F , Fisher Md M 
Published: December 2024

Abstract

Introduction
MED3000 is an FDA-cleared, over-the-counter topical erectile dysfunction (ED) treatment. As MED3000 can be accessed by a mixed group of men with varying levels of ED severity, it is important to assess efficacy in these subgroups.

Objective
To assess the effects of MED3000 in men with mild, moderate, and severe ED using the International Index of Erectile Function – Erectile Function (IIEF-EF) domain score (assessed on both controlled trials for this treatment and Sexual Encounter Profile (SEP) Questions (Q) 2 and 3 (evaluated in one study).

Methods
Two multicenter clinical trials enrolled men with a diagnosis of ED for &gt;3 months according to the NIH Consensus Statement. ED severity was defined by baseline IIEF-EF domain scores (mild = 17 or greater, moderate = 11-16, and severe = 10). Study 1 lasted 12 weeks and study 2 was of 24-week duration. Patients or their female partners were instructed to apply MED3000 immediately prior to sexual intercourse and they were required to make at least 4 intercourse attempts in each of the 4-weekly periods during treatment. Subjects in both studies were instructed to complete the IIEF-EF at the end of each 4-week treatment period and those in Study 1 were also instructed to answer SEP Q2 and Q3 after each intercourse attempt. The changes from baseline for the IIEF-EF domain changes from baseline for each 4-week interval were averaged to provide a mean change from baseline over 12 (Study 1) or 24 weeks (Study 2). The changes from baseline for percentages of patients responding “Yes” to SEP Q2 or Q3 were averaged to provide a mean change from baseline over the 12- and 24-week study periods (average of non-missing data from each 4-weekly visit). The significance of changes from baseline for all measures were determined with paired t-tests. With Bonferroni correction, P &lt; 0.004 was the accepted value for statistical significance for Study 1 and P &lt; 0.0125 was accepted for Study 2. Efficacy analyses were conducted using all subjects who made use of the treatment at least once and missing data were imputed.

Results
Study 1 enrolled 250 subjects (mean age ± standard deviation (SD) = 46.8 ± 12.5 years, duration of ED = 27.5 ± 36.5 months, 59.2%, 28.0%, and 12.8% with mild, moderate, or severe ED, respectively). Study 2 enrolled 48 subjects (44 White, 4 Black, mean age = 46.1 ± 13.5 years, duration of ED = 28.9 ± 32.3 months, 39.6%, 35.4%, and 25.0% with mild, moderate, or severe ED). MED3000 treatment resulted in significant improvements from baseline in the IIEF-EF domain scores over 12 or 24 weeks in total cohorts and those with mild, moderate or severe ED (Table 1). Changes from baseline for IIEF-EF scores in both studies exceeded the minimal clinically important differences (MCID) for mild (2 points), moderate (5 points), and severe (7 points) ED. Results from Study 1 indicated significant improvements from baseline for SEP Q2 and Q3 that also exceeded the MCIDs for these measures for all ED severities.

Conclusions
Results from these studies of MED3000 demonstrated statistically and clinically significant improvements from baseline for IIEF-EF domain scores (both studies) and SEP Q2 and Q3 (Study 1 only), measures commonly employed to assess treatment-related improvements in erectile function, in patients with mild, moderate or severe ED.

Disclosure
Yes, this is sponsored by industry/sponsor: Haleon.
Clarification: Industry initiated, executed and funded study.
Any of the authors act as a consultant, employee or shareholder of an industry for: Haleon.