(223) TOPICAL ADMINISTRATION OF MED3000 GEL SIGNIFICANTLY IMPROVES ALL ASPECTS OF THE SEXUAL ENCOUNTER PROFILE FOR BOTH MEN AND THEIR PARTNERS

Abstract Introduction There is a significant unmet need for an erectile dysfunction (ED) treatment that is efficacious and well-tolerated, works quickly, and facilitates intimacy. MED3000 is a, FDA-cleared, over-the-counter topical gel that is applied to the glans penis by the patient or partner. Objective To assess responses to MED3000 in men and their partners using the Sexual Encounter Profile (SEP). Methods MED3000 was tested in a 12-week, multicenter study that included patients with a clinical diagnosis of ED for >3 months according to the NIH Consensus Statement. Subjects or their partners were instructed to apply MED3000 immediately prior to sexual intercourse and were required to have at least 4 intercourse attempts in each of the three 4-weekly periods during treatment (weeks 1-4, 5-8, and 9-12). Subjects and their partners were instructed to complete the SEP after each sexual intercourse attempt. Mean percentages of subjects and partners answering yes at baseline and mean values and changes from baseline for each 4-week period and for the entire 12-week study were determined. Baseline results and those from the entire 12-week study were compared with paired t-tests. With Bonferroni correction, p < 0.005 was the accepted value for statistical significance. Efficacy analyses were conducted using all subjects who made use of the treatment at least once. Results 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) were treated with MED3000 and all were included in the analysis. For partners, 249 were White and 1 was Asian and the mean age was 43.4 ± 11.9 years. Use of MED3000 resulted in significant improvements in all 5 SEP questions for both subjects and partners over 12 weeks (Table 1). Improvements from baseline for all SEP Questions for both subjects and their partners achieved statistical significance by 4 weeks (P < 0.001). In addition, changes from baseline for SEP Questions 2 and 3 for men exceeded the minimum clinically important difference (MCID, 4 points) for these questions. Conclusions This multicenter study shows that use of MED3000 resulted in statistically significant improvement from baseline for all SEP questions for both subjects and their partners, including achievement of erections, insertion of the penis, successful intercourse, and satisfaction with hardness of erections and overall sexual experience. Disclosure Yes, this is sponsored by industry/sponsor: Haleon. Clarification: Industry funding only - investigator initiated and executed study.