(715) Topical MED3000 Gel Significantly Improved Erectile Function Across a Wide Range Of Erectile Dysfunction Durations

Introduction MED3000 is an FDA-cleared, over-the-counter topical gel for erectile dysfunction (ED), offering a non-systemic alternative to pharmacologic therapies. Understanding its efficacy across varying ED durations is important for guiding clinical use. Objective The present study sought to evaluate the efficacy of MED3000 in men with differing durations of ED using the International Index of Erectile Function – Erectile Function (IIEF-EF) domain scores. Methods Data were pooled from two multicenter, randomized clinical trials that enrolled men diagnosed with ED for >3 months. One trial lasted 12 weeks and the other 24 weeks. Participants were instructed to apply MED3000 before intercourse and attempt ≥4 sexual encounters per 4-week interval. IIEF-EF domain scores were collected at baseline and at 4, 8, and 12 weeks. Subjects were stratified by ED duration: <6 months, ≥6 to <12 months, ≥12 to <18 months, ≥18 to <24 months, and ≥24 months. A linear mixed effects model evaluated changes from baseline with fixed effects for ED duration subgroup, visit number, baseline IIEF-EF domain score, and repeated measures collected at each visit for each subject. Estimated marginal mean differences between baseline and each treatment time point are reported, including the mean difference, standard error (SE), and the respective p-value. The proportion of men achieving ≥4-point improvement in IIEF-EF at week 12 by ED duration subgroup was analyzed by Chi-square test. Results The analysis included a modified intent-to-treat population of 290 subjects with 15.9%, 25.2%, 14.5%, 13.4%, and 31.0% having ED durations of <6, ≥6 to <12, ≥12 to <18, ≥18 to <24, and ≥24 months, respectively. There was a significant improvement from baseline at 4, 8, and 12 weeks (all p<0.0001) for all ED duration subgroups at each timepoint (Table 1). With two exceptions, there were no significant differences in efficacy for any ED duration subgroup versus those with a duration ≥24 months at any time point (Table 1). Percentages of patients with a ≥4-point improvement in IIEF-EF domain scores also were comparable across groups (p=0.7162). Conclusions Topical MED3000 significantly improves erectile function across a wide range of ED durations. Its consistent efficacy supports its utility as an accessible, non-prescription, first-line treatment for men with ED, including those with longer-standing disease. Disclosure Yes, this is sponsored by industry/sponsor: Haleon Clarification: Industry initiated, executed and funded study