SAT-LB7 Acceptability of Oral 11β-Methyl-19-Nortestosterone Dodecylcarbonate (11β-MNTDC) as a Potential Hormonal Male Contraceptive Pill: Results From a Randomized, Placebo-Controlled Trial

Abstract

Background: Injectable hormonal male contraceptives (HMC) injectables appear safe and are effective in clinical trials, but global surveys suggest men would prefer an oral pill. 11β-methyl-19-nortestosterone dodecylcarbonate (11β-MNTDC) is orally bioavailable and well-tolerated. When taken daily with food for 28 days, the drug decreases serum gonadotropins and testosterone without significant impact on mood. If ongoing studies demonstrate that daily 11β-MNTDC consistently suppresses spermatogenesis to <1 million/mL in healthy men, oral 11β-MNTDC could be an effective HMC pill. Surveys of participant satisfaction and method acceptability for promising HMC pill prototypes, like oral 11β-MNTDC, are needed. Objective: To determine satisfaction with and acceptability of a daily oral 11β-MNTDC HMC pill Study Design: In a double-blind, randomized, placebo-controlled trial of a 28-day regimen of daily oral 11β-MNTDC at two academic medical centers, healthy male volunteers completed baseline and end-of-treatment surveys assessing their experience, satisfaction with, and willingness to use daily oral 11β-MNTDC. Results: Of 42 participants, 40 (30 11β-MNTDC, 10 placebo) completed end-of-treatment surveys. Respondents were primarily college-educated, sexually active white men between 21-40 years old. Less than 20% of participants cited initial concerns about safety and missing doses. Following treatment, nearly 90% of participants affirmed that taking the pill was easy to remember and did not interfere with their daily routine. Although one-third (37% 11β-MNTDC vs. 20% placebo, p=0.45) reported bothersome side effects, and 28% (30% 11β-MNTDC vs. 20% placebo, p=0.66) reported potential concerns about safety, these rates were neither statistically different in those taking active drug versus placebo nor associated with method satisfaction. The majority of participants reported satisfaction with the method (73% 11β-MNTDC vs. 70% placebo, p=0.84), that they would recommend it to others (90% 11β-MNTDC vs. 100% placebo, p=0.56), and that they would use the drug regimen as their primary contraceptive even if having to pay (67% 11β-MNTDC vs. 50% placebo, p=0.35). Half of participants (50% 11β-MNTDC vs. 67% placebo, p=0.51) affirmed that the method exceeded initial expectations. Respondents who reported being more likely to miss a dose were also more likely to report dissatisfaction with the study drug (p=0.03). Conclusion: The majority of participants in a 28-day trial of daily, oral 11β-MNTDC pills were satisfied with the regimen, would recommend the drug to others, and would pay to use the drug even when adverse or off-target effects (e.g. changes in libido and/or mood) were considered. If 11β-MNTDC is demonstrated to suppress spermatogenesis uniformly to very low levels, it would be acceptable to men desiring reversible contraception.