Birth Control Pill for Men?
A 28-day course of oral, single-agent dimethandrolone undecanoate (DMAU) has shown promise as a form of male birth control, according to new research.1 Findings from the study were presented on March 18 at ENDO 2018 in Chicago, Illinois.
Similarly to birth control for women, once-daily DMAU combines the activity of an androgen and a progestin, said senior investigator Stephanie Page, MD, PhD.2
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“DMAU is a major step forward in the development of a once-daily ‘male pill’,” Dr Page said in a press release. “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.”
For their study, Dr Page and colleagues tested the effects of 3 doses (100 mg, 200 mg, and 400 mg) and 1 of 2 formulations (castor oil/benzyl benzoate or powder in capsule) of DMAU in healthy men aged 18 to 50 years. A total of 100 participants were randomly assigned to daily oral DMAU or placebo with food.
Ultimately, 83 participants completed the study. At 28 days, the researchers observed a dose response of Cavg for both serum concentrations of DMAU and dimethandrolone. They found that all active treatment groups had achieved reductions of serum testosterone into the hypogonadal range with little between-group differences.
They also observed that all participants treated with the 400-mg powder capsule formulation and most participants treated with the 400-mg castor oil formulation had achieved suppression of follicle-stimulating hormone (FSH) and luteinizing hormone (LH).
The researchers noted that no significant changes in mood, vital signs, or electrocardiogram occurred, although many participants experienced lower high-density lipoprotein cholesterol levels, increased hematocrit, and weight gain.
“Daily oral administration with food of DMAU for 28 days in young healthy men is well tolerated,” the researchers concluded. “DMAU doses of 400 mg, formulated as powder in capsule or in castor oil, suppress serum [testosterone] to near castrate levels and markedly suppress serum LH and FSH. These promising results support further development of DMAU as a single agent oral male contraceptive pill.”
—Christina Vogt
Reference:
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. Paper presented at: ENDO 2018; March 17-20, 2018; Chicago, IL. http://www.abstractsonline.com/pp8/ - !/4482/presentation/6619.
2. Dimethandrolone undecanoate shows promise as a male birth control pill [press release]. Chicago, IL. Endocrine Society. March 18, 2018. https://www.endocrine.org/news-room/2018/dimethandrolone-undecanoate-shows-promise-as-a-male-birth-control-pill. Accessed on March 19, 2018.