Once-Daily Oral Contraceptive for Men Shows Promise

An experimental oral contraceptive for men, dimethandrolone undecanoate (DMAU), suppresses serum testosterone to near castrate levels, markedly suppresses serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels, and demonstrates safety when taken daily for a month, according to an abstract presented at ENDO 2018: The Endocrine Society Annual Meeting, held March 17-20 in Chicago, Illinois.¹

Stephanie Page, MD, PhD, professor of medicine at the University of Washington in Seattle, and colleagues investigated the safety, tolerability, pharmacokinetics, and pharmacodynamics of 28 days of daily dosed oral DMAU at 2 academic sites. One hundred healthy men, 18 to 50 years old, were randomly assigned to receive either daily oral placebo or DMAU with food in 1 of 3 dose groups (100, 200, or 400 mg) and 1 of 2 capsule formulations (castor oil/benzyl benzoate or powder).

They found that all active treatment groups achieved reductions in serum testosterone into the hypogonadal range without significant differences between doses or formulations. However, at the highest dose of DMAU (400 mg) in both formulations, subjects achieved suppression of LH and FSH (<1 IU/L).

Although there were no significant changes in mood, sexual function, vital signs, or electrocardiogram, men taking DMAU did experience mild weight gain, decreased higher-density lipoprotein cholesterol, and increased hematocrit compared with men receiving placebo. There were no serious adverse events, but 9 subjects reported decreased libido (DMAU, n=8; placebo, n=1) and 8 reported acne (DMAU, n=5; placebo, n=3), which resolved by the end of the study.

“These promising results are unprecedented in the development of a prototype male pill,” said Dr Page in a press release.² “Longer term studies are currently under way to confirm that DMAU taken every day blocks sperm production,” she concluded.

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References

1. Thirumalai A, Ceponis J, Amory JK, et al. Pharmacokinetic and pharmacodynamic effects of 28 days of oral dimethandrolone undecanoate in healthy men: a prototype male pill. Presented at: ENDO 2018: The Endocrine Society Annual Meeting; Chicago, IL; March 17-20, 2018. Abstract OR15-2.
2. Dimethandrolone undecanoate shows promise as a male birth control pill [press release]. Washington, DC: Endocrine Society. Published March 18, 2018. Accessed March 18, 2018.