Acceptability of the oral hormonal male contraceptive prototype, 11β-methyl-19-nortestosterone dodecylcarbonate (11β-MNTDC), in a 28-day placebo-controlled trial.
OBJECTIVE
To determine men's satisfaction with and the potential acceptability of 11β-methyl-19-nortestosterone dodecylcarbonate (11β-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 11β-MNTDC for male contraception.


RESULTS
Of 42 trial participants, 40 (30 11β-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% 11β-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 11β-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.


IMPLICATIONS
Oral 11β-MNTDC would be an acceptable and preferable method among men desiring reversible hormonal male contraception (HMC). These data support further trials of novel oral HMCs such as 11β-MNTDC.
['Nguyen|Brian T|BT|', 'Yuen|Fiona|F|', 'Farrant|Maritza|M|', 'Thirumalai|Arthi|A|', 'Fernando|Frances|F|', 'Amory|John K|JK|', 'Swerdloff|Ronald S|RS|', 'Anawalt|Bradley D|BD|', 'Blithe|Diana L|DL|', 'Long|Jill E|JE|', 'Liu|Peter Y|PY|', 'Page|Stephanie T|ST|', 'Wang|Christina|C|']
D003267:Contraception D003272:Contraceptive Agents, Male D004311:Double-Blind Method D006801:Humans D008297:Male D009277:Nandrolone D011795:Surveys and Questionnaires
Male contraception Contraceptive development Hormonal contraception Male birth control Male birth control pill Men's family planning Men's sexual and reproductive health Suppression of spermatogenesis