A new study presented at the recent ENDO 2019 conference in New Orleans suggests the experimental male oral contraceptive – 11-beta-methyl-19-nortestosterone dodecylcarbonate, or 11-beta-MNTDC – did not cause any safety issues for the male subjects. The drug is described as a modified testosterone that combines the behaviors of the male hormone androgen and progesterone.
In the study, presented at of 40 healthy men, 10 participants randomly received placebo capsules and 30 men received 11-beta-MNTDC at one of two doses: 14 men received 200 milligrams and 16 received 400 milligrams. All men took the drug or placebo once a day with food for 28 days.
Levels of two hormones required for sperm production dropped greatly compared to placebo, the researchers found. Among men receiving 11-beta-MNTDC, the average circulating testosterone level dropped as low as in androgen deficiency, but the participants reportedly did not experience any severe side effects. The study’s co-senior investigator, Christina Wang, M.D., Associate Director, Clinical and Translational Science Institute at Los Angeles Biomed Research Institute, Torrance, CA, said drug side effects were few, mild and included fatigue, acne or headache in four to six men each. Five men reported mildly decreased sex drive. Two men described mild erectile dysfunction, but sexual activity was not decreased. No participant stopped taking the drug because of side effects, and all passed safety tests.
Because the drug would take at least three 60 to 90 days to affect sperm production, 28 days of treatment is too short an interval to observe optimal sperm suppression, Wang explained. They plan longer studies, and if the drug is effective, it will move to larger studies and then testing in sexually active couples.
“Safe, reversible hormonal male contraception should be available in about 10 years,” said Wang.
