Acceptability of the oral hormonal male contraceptive prototype, 11 beta-methyl-19-nortestosterone dodecylcarbonate (11 beta-MNTDC), in a 28-day placebo-controlled trial

Objective: To determine men's satisfaction with and the potential acceptability of 11 beta-methyl-19-nortestosterone dodecylcarbonate (11 beta-MNTDC) when used for 28 days as an experimental, once-daily, oral hormonal male contraceptive (HMC). Study design: We surveyed participants from a double-blind, randomized, placebo-controlled, phase 1 clinical trial, examining their experience with and willingness to use daily oral 11 beta-MNTDC for male contraception. Results: Of 42 trial participants, 40 (30 11 beta-MNTDC, 10 placebo) completed baseline and end-of-treatment surveys. Based on a 28-day experience, few cited any baseline concerns about safety and drug adherence. Following treatment, nearly three-quarters (72.5%) of participants reported satisfaction with the study drug and nearly all (92.5%) would recommend the method to others. More than half of participants would be willing to pay for the study drug (62.5%) and indicated that the method exceeded initial expectations (53.9%). Nearly 90% reported that taking the pill was easy to remember and did not interfere with their daily routines. Approximately one-third of participants reported bothersome side effects (37% 11 beta-MNTDC vs. 20% placebo, p = 0.45). Given the option, 42% of participants would prefer a daily HMC pill over injectable regimens or a daily topical gel. Conclusion: A majority of participants in this short-term trial of daily oral 11 beta-MNTDC reported satisfaction with the regimen, would recommend it to others, and would pay to use the drug as HMC despite some bothersome side effects. (C) 2021 Elsevier Inc. All rights reserved.