Abstract Background Benzocaine-containing natural rubber latex (NRL) condoms, with ancillary ejaculation-delaying action, are globally available for use by healthy males. To our knowledge, the efficacy of topical benzocaine to delay ejaculation in healthy males has not been demonstrated in a randomized clinical trial. Aim To determine the ancillary effectiveness of 5% and 3% benzocaine paste-containing NRL condoms to delay ejaculation in healthy males who feel they ejaculate too quickly during vaginal sex, compared with a standard NRL condom. Methods A randomized, three-way crossover study was performed in men aged 18-60 years who reported they “occasionally” feel vaginal sex ends earlier than desired. Participants reported baseline intravaginal ejaculation latency time (IELT) in a 4-week period before randomization to receive different condom types (5% benzocaine paste-containing condom, 3% benzocaine paste-containing condom, NRL control condom) in three 4-week assessment periods. Participants used four condoms minimum per assessment period, with 24 h between each use, and a 3-day wash-out period between assessment periods. Outcomes The primary outcome was IELT change with the 5% benzocaine paste-containing condom from baseline compared to the NRL condom. Patient Global Impression of Change and safety data were collected. Results 148 participants used at least one condom. 143 participants completed the study. All condoms increased IELT from baseline, with the 5% benzocaine condom showing the greatest mean IELT increase of 171.70 s from baseline (P .0001). The 3% benzocaine and NRL condoms increased IELTs by 128.31 (P .0001) and 107.98 s (P .0001), respectively. The 5% benzocaine condom significantly increased IELT versus the control NRL condom (P = .0173), whereas the 3% benzocaine condom did not (P = .4432), although a directional increase suggests dose dependence. Five percent and 3% benzocaine condoms were significantly more likely to make participants feel like sex lasted longer compared to the NRL condom (P = .0068 and P = .0228, respectively) (Patient Global Impression of Change). No serious adverse events were reported, and all condoms were well tolerated. Clinical implications To our knowledge, this study provides the first clinical evidence benzocaine paste-containing NRL condoms prolong the time to ejaculation which is perceptible to users from the general population. Strengths and limitations This study provides the first clinical evidence that topical anesthetic can delay ejaculation in the general population in a perceptible manner. Condoms were debranded; however, unavoidable visible differences remained between test and control condoms due to the benzocaine paste. Conclusion 5% benzocaine paste-containing NRL condoms effectively and perceivably delays ejaculation and are well tolerated in healthy males.
Coupland et al. (Tue,) studied this question.