A study presented at the Congress of Endocrinology (ENDO) 2018 held by the Endocrine Society in the city of Chicago, presented a contraceptive pill for men which seems to be safe when used daily for a month.
“These promising results are unprecedented in the development of a male pill prototype,” said study researcher and lead author Stephanie Page, a professor of medicine at the University of Washington.
The male contraceptive pill is effective when taken once a day for at least one month; evidence of consistent hormonal responses with contraceptive efficacy, as indicated by the study’s researchers, whose results were presented at ENDO 2018, the 100th annual meeting of the Endocrine Society.
Like the contraceptive pill for women, the new male version, still in the experimental phase, is ingested orally. Its active ingredient, called Dimethandrolone undecanoate or DMAU, combines the activity of an androgen (male hormone) and a progestogen, and is taken once a day with food, Page explained.
“DMAU is a major step forward in the development of a once-daily ‘male pill,'”Page said at the Endocrine Society’s annual conference. “Many men say they would prefer a daily pill as a reversible contraceptive, rather than long-acting injections or topical gels, which are also in development.”
The development of a male contraceptive pill has been negatively impacted by the effects of the oral forms of testosterone on the body like the inflammation of the liver, and their fast elimination from the body that would involve 2 doses per day. DMAU contains a long chain fatty acid, which slows down this clearance.
The trial was conducted in 100 healthy men, aged 18 to 50 years, who received one of 3 doses of DMAU (100, 200 and 400 mg) in 2 different formulations inside the capsules. Each study arm consists of a group of 5 participants receiving a placebo and a group of 12 to 15 participants receiving the DMAU. All participants took the drug or placebo for 28 days once a day with a meal. 83 men completed the study. Hormone and cholesterol levels were assessed at baseline and at the end of the study.
The analysis shows an effective contraceptive effect: the highest dose of DMAU, 400 mg, causes a marked suppression of testosterone levels and 2 other hormones necessary for the production of spermatozoa. These very low levels suggest an effective contraceptive effect, according to the authors of the study. And this has no noticeable side effect: “Despite very low levels of circulating testosterone, very few participants reported symptoms associated with testosterone deficiency or excess”.
The side effects, although mild, were a very slight weight gain and a decrease in HDL or “good” cholesterol but no impairment of liver and kidney function. These results are promising and unprecedented in the development of a prototype male pill. But longer-term studies are currently underway to confirm the efficacy and safety of DMAU on a daily basis and in the longer term.