(263) Impact of Benzocaine Paste-Containing Condoms on Event-Level Male Sexual Experience: Findings from a Three-Way Crossover Clinical Trial

Introduction Though condoms are highly effective at preventing pregnancy and STI transmission, it is the perception of sexual pleasure, including condom associated erectile problems (CAEP), which plays a pivotal role in consistent condom usage. We have proven in a three-way crossover clinical trial that natural rubber latex (NRL) condoms containing benzocaine delay ejaculation in the general male population. Through the secondary endpoints we have aimed to assess the male sexual experience whilst wearing benzocaine condoms and NRL condoms without benzocaine. Objective To determine the sexual experience of healthy adult men when using benzocaine paste-containing (5%) NRL condoms, compared with a standard NRL control condom through event-level male sexual pleasure (EMSEX) scale and feeling of improvement in terms of ‘lasting longer’ with patient global impression of change (PGIC). Methods A randomized, three-way crossover investigation was performed in men aged 18-60 years who reported they ‘occasionally’ felt like vaginal sex ended earlier than desired. Participants were randomized to receive a different condom type (5% benzocaine paste-containing condom, 3% benzocaine paste-containing condom [results not reported], NRL control condom) in three 4-week assessment periods, in which participants used a minimum of 4 condoms with 24 hours between each condom-use. All condoms were debranded. Between assessment periods a 3-day wash-out period was required. Participants were asked to complete an EMSEX questionnaire for each condom-use within 2 hours of each coital act. EMSEX results were reported as mean ± standard deviation (SD). Following each condom assessment period, each participant was required to report PGIC and complete a questionnaire on experience with condom-use, acceptability, preference, and tolerability. Results 148 participants used at least one condom. 143 participants completed the study. No serious adverse events were reported. The 5% benzocaine paste-containing condom was significantly more likely to make participants feel like sex lasted longer compared to the control condom (p=0.0068 and p=0.0228 respectively) (PGIC). The total EMSEX scale was not statistically significantly different for the 5% benzocaine-containing condom compared to the NRL condom (p=0.57 respectively). No difference was found in any of the EMSEX sub-scores between condom type. Interestingly, inclusion of benzocaine had no impact on quality of orgasm (‘orgasm was outstanding’; 75.76±18.34 and 76.23±16.53 for the 5% and NRL condom respectively), sensation felt (‘The physical sensation on my penis was outstanding’; 70.37±20.62 and 70.96±21.11 order as above), general pleasure (‘This sex was very pleasurable’; 77.36±17.61 and 77.13±16.72 order as above), ability to maintain erection (83.85±16.91 and 85.85±14.80 order as above) or firmness of erection during sex (71.77±21.08 and 73.56±20.37 order as above). Furthermore, >50% were satisfied with effectiveness and tolerability and >70% with the usability of the condoms. Conclusions To our knowledge this is the first study utilising the EMSEX scale to assess sexual pleasure with benzocaine paste-containing condoms. Furthermore, the results demonstrate the first clinical evidence that despite the presence of benzocaine paste, users of the benzocaine condom reported the same level of sexual pleasure as the NRL condom. In addition, the benzocaine paste addition did not impact pleasure, sensation or erection. Disclosure Yes, this is sponsored by industry/sponsor: Reckitt Benckiser Healthcare International Ltd Clarification: Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Reckitt Benckiser Healthcare International Ltd