(147) TOPICAL ADMINISTRATION OF MED3000 GEL SIGNIFICANTLY IMPROVES SELF-ESTEEM AND RELATIONSHIPS IN MEN WITH ERECTILE DYSFUNCTION: RESULTS FROM TWO CLINICAL TRIALS

Abstract Introduction Erectile dysfunction (ED) negatively impacts self-esteem, confidence, relationships, and quality of life while effective treatment of ED improves these measures. MED3000 is a FDA-cleared, topical treatment for ED that has been shown to be effective for the treatment ED, but effects on psychosocial outcomes have not been reported. Objective To assess the effects of MED3000 in men with ED using the Self-esteem and Relationship (SEAR) questionnaire. Methods Two multicenter studies were performed (n = 298 total). Both studies enrolled patients with a clinical diagnosis of ED for >3 months based the National Institutes of Health Consensus Statement. The first (Study 1) had a duration of 12 weeks and the second (Study 2) was 24 weeks. Subjects or their female partners were instructed to apply MED3000 immediately prior to sexual intercourse and subjects were instructed to make at least 4 intercourse attempts in each of the three or six 4-week periods during treatment. Subjects completed the 14-item SEAR questionnaire every 4 weeks for the duration of the study periods. Results for individual scores were combined and transformed into domain and total scores (1-100, higher scores indicate more favorable responses). Results for non-missing data for each 4-week period were combined to provide a mean change from baseline over 12 (Study 1) or 24 (Study 2) weeks. Significance (P < 0.005 with Bonferroni correction) of mean changes from baseline over 12 or 24 weeks were determined with paired t-tests. Results Study 1 enrolled a total of 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, 46.1□13.5 years old, duration of ED = 28.9□32.3 months, 39.6%, 35.4%, and 25.0% with mild, moderate, or severe ED). In both studies, MED3000 resulted in statistically significant improvements in total scores and for all individual SEAR domains except Overall Relationship Satisfaction in Study 2 (Table 1). Results from both studies indicated that SEAR total and domain score changes from baseline exceeded the minimal clinically meaningful improvement (>10 points) for this measure. At the end of the trial, 81.2% of men in Study 1 and 85.4% in Study 2 felt that sex could be spontaneous. Table 1. SEAR questionnaire results (mean ± SD) Study 1 (N = 250) Study 2 (N = 48) Baseline Change from Baseline over the 12-week Period P-value Baseline Change from Baseline over the 24-week Period P-value Total Score 38.7 ± 15.9 14.7 ± 18.6 < 0.001 44.6 ± 17.5 12.5 ± 16.8 < 0.001 Sexual Relationship and Satisfaction Domain (MCMI >10-point change) 38.1 ± 17.1 15.6 ± 19.9 < 0.001 41.9 ± 19.6 13.8 ± 17.9 < 0.001 Confidence Domain (MCMI >10-point change) 39.4 ± 15.9 13.6 ± 18.9 < 0.001 48.2 ± 16.1 10.8 ± 16.6 < 0.005 Self-esteem Domain (MCMI >10-point change) 38.2 ± 15.4 11.8 ± 17.4 < 0.001 42.6 ± 14.6 11.1 ± 18.3 < 0.001 Overall Relationship Satisfaction Domain (MCMI not defined) 41.9 ± 23.4 17.1 ± 28.1 < 0.001 59.4 ± 27.2 10.1 ± 24.5 0.009 MICI, minimal clinically meaningful improvement. Conclusions Study results from two multicenter trials showed that MED3000 resulted in statistically significant and clinically meaningful improvements in self-esteem and relationships as reflected by SEAR total and domain scores. These findings provide further support for the benefit of MED3000 in men with ED. Disclosure Yes, this is sponsored by industry/sponsor: Futura Pharmaceuticals/Haleon. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Futura and Haleon.